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<![CDATA[Innovative pharmaceutical company seeks Mechanical Engineer to champion embedded system design, packaging, testing and manufacturing electromechanical systems used in small, hand-held, battery powered drug delivery devices. The Lead ME will play a major role in taking medical products to market, managing outside design activities and manufacturing transfer onto verification and validation. Key areas of Responsibility: 1. Package and mechanism design, sensor interfaces, user interface including human factors, functional analysis and supply chain management. 2. Manage outside contract manufacturers 3. Design verification and performance validation 4. Design documentation, test protocols, execution and test reports Requirements BSME with 7 years product development experience. Demonstrated ability to design mechanical systems. Success in taking 2 medical products to commercial manufacturing. Ability to design plastic molded parts. Working knowledge of internal and external supply chain management. We seek highly creative individuals with excellent written and oral communication skills, able to work within a multidisciplinary team approach. ]]>

<![CDATA[Research facility currently seeking a lead quality systems professional to develop and implement a Laboratory Quality System for a molecular virology and vaccine application. The selected candidate will provide leadership and technical assistance amongst a diverse team of leading researchers to support and oversee site capabilities, infrastructure, strategic planning, implementation & maintenance of Quality System. Will support quality team to ensure future development of assays and method validation procedures are met in accordance to Good Laboratory Practices (21 CFR Part 58) for vaccine and diagnostic reagents produced. Must evaluate equipment and validation procedures as necessary and study specific procedures (SSP) and standard operating procedures (SOPs) to align with future initiatives. Will assist QA Manager to develop new systems, procedures, document and version controls of software and hardware and conduct periodic audits as necessary. Required Skills: BS/MS in biotechnology, microbiology, virology, clinical chemistry, nursing or medical technology with at least 5 years recent experience in quality assurance and quality systems development (QSR, GCP, GLP). Must have post academic work experience within a microbiology or diagnostic FDA regulated and/or CLIA certified laboratory with demonstrated expertise in design, implementation and auditing of laboratory operations. Must be able to effectively communicate amongst a diverse team of individuals, at all levels, both orally and in writing. Certified Quality Auditors with backgrounds in CBER and 510k submissions encouraged to apply. Excellent benefits to include health insurance, dental, Paid Time Off, holidays, etc. ]]>

<![CDATA[We currently have a great opportunity for an experienced chemist in the Houston, TX area. My client is an international chemical and petrochemical manufacturer that is headquartered in the Houston area. Last year they had more than $10 billion dollars of revenue! The company is looking for experienced chemists to work in their high tech state-of-the art analytical lab, it's truly every chemists' dream job. The positions would be located in the North American Technical Center, there is only one other location in the world similar. Great room for advancement, autonomous work environment, full benefits to include relocation and tuition reimbursement. Analytical Spectroscopy Chemist MS or PhD required Experience with : LC/ MS, GC/MS, IR, UV-VIS, FTIR, NMR, NearIR Expertise in Spectroscopy, Instrumentation, General Chemistry Techniques 20% Method Development; 50% Unknown Determinations; 30% Analysis & Characterization. Extensive LC/MS experience a must!!! 5+ years of experience required. Must be able to work independently and complete unknown product characterizations w/ little guidance.]]>

<![CDATA[Remember when your career dreams were limitless? They can be again when you work with Yoh Pharmaceutical Industrial Postdoctoral Scientist-Wilmington, DE 3 year assignment **Qualified candidates must be legally authorized to be employed in the Unites States. Sponsorship for employment visa status (e.g., H-1B or TN status) is not available for this position** We've been delivering the best talent to America's leading companies for the past 7 decades - longer than any of our competitors. These customers count on our experience, time-honored processes, responsiveness and market intelligence to build their businesses. Most importantly, they look to Yoh to deliver talent with fresh ideas and empowered minds who want to fulfill their potential. People like you. Life's short. Live your dream. Tell us where you want to work. What you want to do. And we'll help get you there. Yoh Managed Staffing has an opening for a Pharmaceutical Industrial Postdoctoral Scientist in Wilmington, DE. Our customer is a premiere world wide pharmaceutical company headquartered in Wilmington, DE. Description: A postdoctoral position is available in the Molecular and Investigative Toxicology Section of the Safety Assessment Department at our client’s Wilmington, Delaware site. The successful candidate will participate in a research program that focuses on problem solving in the area of the neuroendocrine control of male reproductive pathology. Research will be undertaken to understand the impact of perturbation of the hypothalamic/pituitary/adrenal (HPA) axis on the male reproductive tract. These studies will require clear understanding of genetic principles, pharmacology, cell and molecular biology, and cross-species integrative physiology. Cross species analysis of perturbations of the neuroendocrine axis and its impacts on indicators of male reproductive pathology in model organisms is desired. Strong written and oral skills, as well as team-oriented behavior are required. Responsibilities: • Design, implement, and perform investigative studies, perform data analysis, present and publish data in scientific journals and at scientific meetings. • Maintain an awareness of new techniques relevant to the field of study, such that work in progress utilizes current methods. • Contribute to the efficient running of the Molecular and Investigative Toxicology laboratory. Qualifications: • PhD in Neuroendocrinology, Pathology, Cell/Molecular Biology or related areas • Neuroendocrine, cell, molecular, and genetic experience • The ideal candidate should have an interest in Neuroendocrine Control of Male Reproductive Pathology • Effective communication skills including technical writing is required. • Qualified candidates must be legally authorized to be employed in the Unites States. Sponsorship for employment visa status (e.g., H-1B or TN status) is not available for this position. These positions offer vacation time, medical benefits, and relocation assistance. Discover all that’s possible with Yoh Managed Staffing. Apply now. ***Please send your resume to kelly.kingera@yoh.com***susan.hartz@yoh.com Partnering with Yoh In addition to great career opportunities, consulting with Yoh comes with its perks: • Competitive compensation plans • Wide variety of benefit options • Yoh Advantage - our consultant rewards program that offers discounts and perks at leading companies and with national brands exclusively for Yoh About Yoh Yoh is one of the largest providers of talent and outsourcing services to customers in the United States. With over 374 million USD in total sales, Yoh operates from more than 75 locations and provides long- and short-term temporary and direct placement of technology and professional personnel, as well as managed staffing services, for the information technology, scientific, engineering, health care and telecommunications communities. For more information, visit yoh.com. Yoh is part of Yoh Services LLC, a Day & Zimmermann Company. Yoh is an Equal Opportunity Employer. M/F/H/V. Looking for a great career opportunity? Visit www.yoh.com ]]>

<![CDATA[Clinical research facility specializing in central nervous system disorders is seeking candidates for the position, Rater. Incumbent will perform various neuro-cognitive test evaluations, interviews and ratings on study participants specific to study protocol. Minimum Requirements: Master's degree in Psychology. Experience with central nervous system disorders a plus. Full-time position, M-F, 8:30am - 5pm. Incumbent is eligible for fringe benefits after satisfactorily completing a 90 day probationary period. To apply, please forward resume or cv by email. ]]>

<![CDATA[Job Summary: Responsible for developing and enhancing the company's process of using electromagnetic energy for the energy beneficiation and environmental attributes of solid fuels. This hands-on position will include developing a deeper understanding of the fundamentals of microwave/RF interaction with solid fuels and leverage this to developing new products and processes. This position will require a fundamental understanding of microwave/RF interactions with materials as well as a knowledge of industrial processes. A background in chemical engineering or material science is also highly desirable preferably coupled with microwave processing. Education / Experience: • Master’s degree or better in microwave engineering, chemical engineering or material science or equivalent experience • 5+ years of work experience • 3+ years experience with industrial microwave systems ]]>

<![CDATA[Hello my name is Theus Monroe and I need a chemist to configure the components to make my produts. I have an idea of what I want my products to smell like and react to heat. I just need someone who knows the chemical knowledge to help me. If you are interested please give me a call at 4045399175 or email me at theus_aura@yahoo.com Thanks. ]]>

<![CDATA[World-class biotech company with a location in the general area is currently seeking a skilled professional to fill a regular, full-time position. The position offers excellent benefits and an opportunity for advancement. For a direct link to the detailed job description, employer information, and to apply online directly, please visit our website. A background in biotechnology, biology, chemistry, pharmaceuticals, etc. is generally required. Previous relevant experience is a requisite, along with any essential skills, training, education, etc. The ideal candidate will have the ability to take initiative, work independently and in a team setting, and multi-task effectively. <a href="http://ebiotechcareers.com/job.opening.htm" rel="nofollow"> Research Associate Position - Details / Apply</a> If you work in the field of Biotechnology / Research (Biological Scientist, Clinical Lab Technologist, Research Scientist / Associate, Medical Scientist, Lab Technician / Associate, Biotech Sales / Marketing / Administration, etc.), please visit our website. Equal Opportunity Employer - EEO/AA M/F/V/D Atlanta, GA]]>

<![CDATA[An environmental lab has an opening for an oil and grease analyst. Experience with Horizon oil and grease instrumentation is a plus. A degree in the science field is required. Applicant must be able to multi-task, be organized and reliable. Applicant must be available to work overtime and weekends when necessary.]]>

<![CDATA[A leading environmental company is seeking an experienced Chemist for a high production Volatile Organics laboratory. Must be proficient in EPA 8000 series methods and level IV data deliverables. Working knowledge of Instrument Maintenance, TIC’s and SIM techniques essential. BS Chemistry with GCMS experience mandatory. Must be able to multi-task and work in high pressure, fast-paced environment. Flexible work schedule. Current and applicable computer skills necessary.]]>

<![CDATA[We have been retained by a food manufacturer with 20 plus years of presence in the U.S., to assist them in the recruitment of a Director Food Safety and Quality. A nationally known leader in their field, our client is focused on the development and supply of health nutrition products. These include dairy, bakery, confectionary, fruit beverage and food service markets. Quality assessment and management is a key performance indicator for the company, ensuring safe- high quality products to their customers. This will be a highly visible position within North American organization. The Director of Food Safety and Quality will report to the Vice President of Operations. QUALIFICATIONS: BS Degree in Food Science, Agriculture, Engineering, Biology/Chemistry or equivalent. Minimum of 10 years of quality/operational/technical experience with at least five years of progressive management experience in Quality Management. MS in Food Science, Biology/Chemistry preferred. Minimum three years of quality experience in the food, beverage, pharmaceutical and similar industries. Aseptic processing experience a plus. Fruit experience a plus. Must have been a Plant Quality Manager. Corporate Quality experience is a plus. Must have a strong background in SPC, continuous improvement and process management and control. Six Sigma and/or Total Quality experience a plus. Must have prior experience working with major customers. B2B background a plus. Market and Customer Orientation, ability to understand market and meet the needs of external and internal customers. Achievement Orientation, ability to make decisions, take responsibility for actions and able to handle crisis. Ability to travel 50%. Willingness to relocate to Midwest. ]]>

<![CDATA[Job duties include: -Performing quality assurance evaluations in all packaging and processing areas, including raw materials, in process and finished products. -Inspect food products and ensures quality of finished product through preoperative checks on each packaging line. -Maintain quality assurance lab instrumentation, logs, and data bases. 12.00 - 14.00 USD /hour]]>

<![CDATA[Description: Experienced Regional Clinical Research Associates are being sought for one of the top large pharmaceutical companies in the world! Supporting new drug applications, the Regional CRA monitors clinical trial activities in compliance with FDA regulations, ICH/GCP guidelines, and company SOPs. As specified in the monitoring plans, you will support project teams in the placement, implementation, evaluation, and conclusion of clinical studies. This role lets you use your exceptional interpersonal and communication skills to develop rapport with potential investigators to facilitate the pharmaceutical company's full site management model. This is a full time, long term, W2 salaried contract position with full benefits! If you are an experienced Regional CRA with complex therapeutics experience, we have excellent career opportunities waiting for you today! Requirements: For consideration to these positions, you must possess 3 or more years of experience as a fully independent home based monitor, and you must hold a Bachelor's degree, preferably in a scientific or nursing discipline. Phase I experience is required. Oncology experience is also required. Travel within the assigned region for this opportunity is anticipated to be near 70%. Due to the precise requirements of this position, we will only be contacting candidates that meet all of the listed criteria. If you are qualified and interested, apply today! Apply: <a href="http://www.bioemployment.com" rel="nofollow">http://www.bioemployment.com</a> ]]>

<![CDATA[We are a leading US manufacturer and distributor of quality natural health products and over-the-counter pharmaceuticals. With over 70 years experience in pharmaceuticals, we are seeking one dynamic individual to join our team. MARKETING MANAGER Reporting to the Vice-President, Innovation and Customer Care, you will have the opportunity to manage the Canadian launch of some of the largest U.S. National Brands in the vitamin and health supplements category. You will manage all aspects of our Brand development initiatives in Canada including new product launches, advertising and promotional planning and execution, brand review presentations and analysis, brand web site development, and the overall P&L for each brand. You will work closely with all functional groups including sales, new product development, operations, legal, finance, regulatory, quality, advertising, and your Canadian counterparts. In addition, you will also be responsible for managing relationships with external agencies and consultants. An energetic self-starter, you possess a university degree in Business, Marketing, or a related field, combined with a minimum of five years Marketing experience with a leading US Company. It is integral that you have branded consumer products experience preferably with Natural Health Products (NHP's) and/or Over- The-Counter Products (OTC's). You are a leader with excellent oral and written communication skills and the ability to develop sound relationships. You are proficient with the use of Microsoft Office applications. You must be willing to travel up to 25% of the time to Canada and New-York. This position will base out of our Sales office in Atlanta. If you would like to become part of our organization, please submit your resume, specifying position applied for and including salary expectations, ]]>

<![CDATA[Global in-vitro diagnostics company looking for a blood banking professional with proven leadership skills and technical strength to direct QC laboratory. Will be responsible for ensuring compliance with FDA, ISO and OSHA prior to product release. Will assist team with daily tasks and review records for completeness, accuracy and conformance. Will manage and oversee scheduling, employee training, performance appraisals & other related activities. QC Manager will be expected to write, revise and edit forms, to include SOPs, for accurate FDA records compliance on products with minimal direction. Will assist with department's out-of-spec results and lead employees to ensure proper measures are taken to meet internal deadlines. Other duties as directed. Monday thru Friday operation. Required Skills: BS in Science required. Must have MLT or MT (ASCP and/or SBB certification required) with at least 10 or more years cumulative recent experience working in a commercial laboratory (centered around blood banking) and/or coupled with some previous experience in a hospital or university type setting. Must have at least five years laboratory management experience within a blood bank/clinical laboratory. Must be proficient with recent test methods (CLIA, FDA) as it pertains to operating and managing a blood bank laboratory where he/she was adept at managing and mentoring both MTs/MLTs on manual serological procedures. ]]>

<![CDATA[Scarano Group, Inc. (SGI) is a growing leader in the health and safety consulting field. SGI is searching for qualified candidates who are energetic, self-motivated, and enjoy challenges. SGI has an exciting industrial hygiene technician position open at this time. The primary responsibility shall be with the Centers for Disease Control and Prevention’s (CDC) Respiratory Protection Program. The candidate shall be required to perform hands-on training in all types of respiratory protection as well as fit testing. Additionally, the candidate shall be required to conduct a wide variety of environmental and occupational exposure monitoring and sampling to include, but not be limited to: asbestos and lead-based paint sampling and monitoring; chemical hygiene exposure sampling, and noise monitoring. Minimal travel may be required. The candidate shall show competency in preparing field documentation in a timely and organized manner. Candidates must possess a minimum bachelor’s degree from an accredited university in industrial hygiene, environmental health, occupational health, or a related field. Prior experience and/or certifications are preferred but not required. Candidates must be able to demonstrate verbal and written communication skills during the interview process. Candidates must have detailed organizational skills as well as interpersonal skills in order to communicate with a wide variety of clients. First aid and CPR training is encouraged. Candidates must possess proficient computer skills, in particular, Microsoft Office®. Candidate must be able to successfully pass a Department of Health & Human Services security background check, must possess a valid driver’s license and have personal transportation. This position is eligible for health, retirement and other benefits after a 90 day probationary period. For consideration, send or email letter of interest, resume, and three references with phone numbers to: Mrs. Gina McCall Human Resources Department Scarano Group, Inc. 900 Circle 75 Parkway, SE Atlanta, GA 30339 gina@scaranogroup.com ]]>

<![CDATA[Private Corporation seeking someone with 3-4 years of Research Analyst experience to perform historical investigations of hazardous waste sites. Responsibilities include collecting records, conducting interviews, preparing environmental historical reports, and developing work plans/cost proposals. BA/BS degree required. Successful applicants must have excellent written/oral communication skills. Familiar with CERCLA and related environmental regulations a plus. This is a contract position which will last for five years. Needed stable applicants for this position. ]]>

<![CDATA[Global in-vitro diagnostics company specializing in the area of pre-transfusion diagnostics is seeking a consultant for their laboratory. Candidate will perform standardized stability studies, product testing and inspection for compliance within the quality control department [Monday thru Friday, 1st shift]. Testing will include but not limited to potency, specificity, hemagglutination assays, reactivity and various wet chemistry testing (pH, chloride, absorbance, etc). Will maintain accurate records according to current Good Manufacturing Procedures (cGMPs), report out-of-specification results to upper management and perform product release requirements. Required Skills: MLT or MT (ASCP certified pref) with experience working in a commercial laboratory (blood bank) or hospital blood bank laboratory where he/she is adept at performing manual serological procedures to include immunohematological testing. Candidate must be comfortable operating laboratory equipment to include: centrifuges, incubators, cell washers, etc. Those individuals with previous hands-on experience running Galileo or Echo encouraged to apply.]]>

<![CDATA[Quality Control department for a growing biologics organization looking to hire a scientist to perform and be trained in specific molecular testing using real-time polymerase chain reaction (RT-PCR). Will perform in-vitro molecular assays of product raw materials, production intermediates, finished products, etc. Must maintain excellent document records and accurate laboratory notebook as required by FDA. Will assist team in maintaining a clean work area. All testing and documentation will be in compliance with Good Laboratory Practices and in-house Standard Operating Procedures. Required Skills: BS/BA in microbiology, molecular biology, or related science with a minimum of one year experience performing RT-PCR (post-graduate). Must have excellent academic track record, to include GPA >3.0. Prior bench experience working in a GLP or cGMP industry preferred. ]]>

<![CDATA[Growing research organization seeks qualified Scientist to support the Quality Control department dedicated to the production and distribution of in vitro diagnostic products. Will be responsible for performing routine molecular testing using real-time polymerase chain reaction (RT-PCR) and DNA sequencing when necessary to ensure specifications. Will perform in-vitro molecular assays of product raw materials, production intermediates and bulk samples and finished product. Will also be involved in reporting environmental monitoring, process & cleaning validation samples. Must be able to identify and report to management team in timely manner any technical issues, atypical and out of range test results. Will be held responsible for maintaining excellent document records to include current inventory of supplies, reagents, etc. All testing and documentation will be in compliance with Good Laboratory Practices (GLP), FDA and in-house Standard Operating Procedures (SOPs). May assist in developing and writing SOPs for new methods on future product modifications. Required Skills: MS in microbiology, molecular biology, or related science with a minimum of 3-5 years experience performing RT-PCR including data analysis in a GLP regulated laboratory (non-academic). Incumbents with BS degrees may apply with a minimum of 8-12 years industry experience using RT-PCR. Excellent medical benefits with company contribution, dental plan, paid time-off and holidays paid! First shift requirements, Monday thru Friday. ]]>

<![CDATA[Quality Assurance Specialist needed to support the implementation, oversight, and maintenance of Quality System processes for vaccine and biological products laboratory unit. Will work to support management to assess current capabilities, processes, and future compliance needs to execute and develop a quality management plan for specific research laboratories. Will maintain Quality System infrastructure through ongoing analysis and evaluation of quality processes and procedures; coordination of reviews, internal audits, and implementation of corrective actions. Required skills: B.S. Biomedical, Microbiology, biochemistry or related life science at least two years experience in quality assurance and quality systems within one or more of the following areas: vaccines, biological products manufacturing and/or in vitro diagnostics (IVD). Working knowledge of GLP, GMP and QSR. Strong interpersonal, oral and written communication skills. Knowledge of CLIA regulations a plus. Full medical benefits with company contribution, paid time-off (PTO) and holidays. First shift hours, Monday thru Friday. Local candidates encouraged to apply. All non-Georgia residents must be willing to relocate at his/her own expense.]]>

<![CDATA[Research facility currently seeking a Quality Assurance Manager for the oversight, planning, implementation, and maintenance of a Quality System for numerous biological laboratories performing in vitro diagnostic development, vaccine development, and research. The selected candidate will provide leadership and technical assistance amongst a diverse team of leading researchers to support and oversee site capabilities, infrastructure, strategic planning, implementation & maintenance of Quality System. Will work in conjunction with upper management to assess current capabilities, processes, and future compliance needs to execute and develop a quality management plan. Will maintain the Quality System infrastructure through ongoing analysis and evaluation of quality processes and procedures; coordination of reviews, internal audits, and implementation of corrective actions. Will assist in identifying and providing oversight of new team members to include training. Must be able to effectively communicate amongst a diverse team of individuals, at all levels, both orally and in writing. Required Skills: M.S. in Biomedical Field to include Biochemistry, Microbiology, Biology or related life science with at least eight years experience in Quality Assurance with proven success in implementing quality systems within biological products manufacturing, biopharmaceuticals, vaccines, or in vitro diagnostics (IVD). Must have interacted directly with the FDA and have working knowledge of GLP and QSR. Excellent team lead and supervisory experience required. Applicants should also have exposure to CLIA, CBER, 510k submissions and ISO 13485 requirements. ]]>

<![CDATA[National A/E consulting firm has an opening for an Industrial Hygiene Technician in their Atlanta office. Ideal candidate should possess current certifications, with a minimum of 1 year experience performing asbestos, mold and lead-based paint projects. Any IAQ experience a plus. EOE Please include your salary requirements with your resume.]]>

<![CDATA[The Atlanta Center for Medical Research is currently enrolling participants; both male and female (18-60 years); for a clinical study examining the efficiency of an investigational drug in the treatment of Depression symptoms. This drug is FDA approved. When participating in the study, all study medication and medical assessments are provided at no cost. No insurance needed! ]]>

<![CDATA[The Atlanta Center for Medical Research is currently enrolling both male and female study participants(18-50 yrs)for a clinical study testing the efficiency of an investigational drug in the treatment of symptoms associated with ADHD. This drug is FDA approved. When participating in the study, all study medication and medical assessments are provided at no cost. No insurance needed!]]>

<![CDATA[Analytical Environmental Services, a growing and sucessful laboratory, is seeking a Data Reviewer. The candidate must have a Bachelor's degree in a Physical or Life Science(Chemistry, Environmental Science, Physics, Biology, Microbiology). Must have at least 6 months experience in customer service and general office duties. The duties include the following: assist project managers with daily tasks(data entry, printing,filing, faxing, photocopying, etc..)and assist with other assigned projects as needed while learning hold times and test codes for samples. Must have good organizational and communication skills, have the ability to work nights and weekends if necessary and the ability to function in a fast-paced environment and work well under pressure. The schedule is M-F 9AM-6PM 4days & 10AM-7PM 1 day. Opportunity for advancement, depending on experience and training.Salary range $26K-$32K/YR(starting salary range based on expereince).Opportunity for a performance-based salary increase after 90 days. We are a drug free workplace. PLEASE DO NOT CALL EMPLOYER. Please visit us at www.aesatlanta.com ]]>

<![CDATA[The Compliance Specialist is responsible for assuring FDA / ISO Compliance activities are recognized, prioritized, and completed in an accurate and timely manner. This is a key compliance role and will interface directly with regulatory authorities and other sites. This role will serve as the primary back up to the QA Manager in Compliance matters. Duties and Responsibilities: General: 1. Internal auditing – 15%: • Schedule the Grayson site internal audit program to assure all areas are audited according to schedule. • Completes audits and records data. • Tracks and trends audit ANRs and suggestions improvement to compliance program. • Develop ideas that will continuously improve the company’s systems and/or products through corrective actions and preventive actions. Developing the actions needed and driving the changes through to completion. 2. CAPA Coordinator – 15%: • Performs risk assessment on potential issues to determine if a CAPA is needed. • Assigns CAPA. Tracks and monitor ongoing CAPA to assure completion dates are met. • Meets with investigators, assists in designing experiments. Documents activities. 3. Trend and Risk Analysis – 15%: • Review of quality system documents such as waivers, PCARs, batch records, for accuracy and completeness. • Meet with regulatory authorities and serve as a QA liaison during audits of the facility. 4. Change control – 20%: • Documents changes according to procedure. • Monitors ongoing changes to assure timeliness of completion. • Assures all affected areas are aware of the change. 5. Complaint handling – 20% • Assign complaint investigations, testing product or arranging for testing, and providing thorough documented results. • Track and trend complaint data to investigate for potential corrective and preventive actions. • Accurately create reports to local and Global Quality groups. 6. Other activities – 15% • Stability Coordinator - assign stability studies and arranges for samples and testing. Reports data. • Performs supplier audits as needed according to annual plan • Reviews animal origin information • Reviews Environmental data • Become a team member on special projects. Cross train and become proficient in product testing as needed. Cost Center Specific: None Minimum Qualifications: Knowledge/Skills: Detailed working knowledge of Medical Device Regulatory complaince activitives, inclduign interprestation, implementaiton and monitoring of compliance actions. Demonstrated ability to work effectively in a team based environment. Ability to communicate clearly and effectively (verbally and written) with all levels within and outside the organization. Education: Bachelor’s Degree Level. Experience: Minimum 3 years Compliance experience in an ISO and GMP scientific or technical environment. Minimum 2 years of Practical Knowledge of the application of FDA’s Quality System Regulations and ISO 9000 requirements. ]]>

<![CDATA[Responsible for several functions within materials management department to include SAP master data, label control and buyer / planner duties. Duties and Responsibilities: General: Coordinates SAP data entry for material introduction, change and discontinuation through defined processes, participates in the analysis of master data, and communicates the business data findings. Effectively partners with applicable departments to ensure cross-functional integration of information and processes. Reviews functional specifications to ensure business requirements are met. Additional responsibilities include label control activities, both creation of and maintenance of all labels and package inserts. Buyer / planner duties to include support of all non-inventory procurement activities and support of production planning activities through the use of SAP. Cost Center Specific: x Minimum Qualifications: Knowledge/Skills: 1. A general understanding of business processes is necessary; specifically, how processes integrate cross-funtionally. 2. Requires a demonstrated ability to function independently. Must possess tolerance for dealing with ambiguity. Analytical, quantitative, and problem solving skills are needed. 3. A proven ability to develop and maintain professional relationships with internal groups and departments is important. Requires moderate to advanced knowledge of Microsoft Word are Microsoft Excel; basic knowledge of PowerPoint, Access, Project and/or Visio is a preferred. 4. Ability to listen and communicate effectively, both verbally and in writing is a must. 5. Previous project management experience is preferred. Education: Requires a BS degree, preferably in Business or Science. Experience: Minimum of two years experience working in-depth with an ERP system (preferable SAP). ]]>

<![CDATA[About the Company: Bracy Analytics is a Statistical Analysis Consulting Firm that started in 2003. We provide services in three primary areas: Data Management, SAS Programming, and Statistical Analysis. We also have a product to standardize clinical trials data and produce clinical reports. Bracy Analytics services and products may be provided individually or in combination to meet the specific needs of each client and each project. Summary: We are looking for an Experienced SAS Programmer for our upcoming job opening located in Atlanta, Georgia. Requirements Qualifications and experience: Qualified candidates must possess a B.S./B.A. or M.S. Degree in computer science, mathematics, statistics or related areas of study. In-depth knowledge of SAS programming with at least 2 years of experience in a pharmaceutical and healthcare environment. Strong knowledge of SAS Macro. Please send CV and salary requirement for consideration to courtney@bracy-analytics.com. **PLEASE NO 3rd Party Vendors** Bracy Analytics is an equal opportunity employer; we are not sponsoring Visas at this time. ]]>

<![CDATA[A highly motivated, independent, and experienced individual with a minimum of a BS in a biomedical science or engineering discipline is needed immediately for a full-time research position in a cell and molecular biology laboratory. A combination of critical analytical thinking skills, technical competency and strong written and oral communication skills are necessary for this position. Technical responsibilities will include conducting cell culture experiments with different mammalian cell lines and performing various molecular biology and biochemical assays (qPCR, IHC, WB, ELISA). In addition, this individual will be asked to perform data analysis, provide written reports, and assist with the preparation of manuscripts and grant proposals.]]>

<![CDATA[ Department: Biostatistics Position Title: Associate Director, Biostatistics Reports to: Director, Biostatistics Job Summary: Working with the director, oversee and manage all operational aspects of the biostatistics department. Apply a high level of managerial and technical expertise to help lead and develop the biostatistics staff. Serve as a lead statistician on clinical studies and provide senior level peer review of work being accomplished by other biostatisticians in the department. Maintain the statistical and analytical integrity of clinical trials analyzed by the Corporation. Actively participate in writing statistical sections of protocols, preparing statistical analysis plans, preparing data deliverables for clinical study reports, interpreting analysis results, writing statistical sections of clinical study reports, and participating in meetings with drug regulatory agencies as required. Support business development and project management with strategic planning, proposals, pricing, and timeline planning. Primary Responsibilities: · Oversee day-to-day project, developmental, and consulting biostatistics analysis processes and results · Serve as subject matter expert during client and vendor meetings for biostatistics analysis support · Actively support business development in capabilities presentations to prospective and current clients · Effectively manage department and clinical study budgets for biostatistics analysis support · Develop, coach and mentor biostatistics department personnel · Act as the lead statistician on clinical research projects and help with SAS programming, as required · Provide statistical expertise for study design of clinical trial protocols · Write statistical methods section of the study protocol, as needed · Write statistical analysis plans ensuring appropriate regulatory requirements and study objectives defined in the study protocol are followed · Review CRFs to ensure consistency with protocol and statistical analysis plan (SAP) · Program summary tables, data listings and graphical representations of clinical trials data · Perform all analyses defined in the statistical analysis plan as well as any post-hoc analyses and relevant exploratory analyses of clinical trial data · Prepare key sections of clinical study reports and various regulatory documents · Perform statistical QC of all department outputs including analyses and clinical study reports · Provide statistical support to answer questions from external clients (such as FDA, Investigators) · Contribute to the development, maintenance, and training of standard operating procedures (SOPs) · Represent the biostatistics department at regulatory meetings, sponsor meetings, and any other multifunctional meetings, as needed · Adhere to all aspects of the Corporation’s quality system. · Comply with the Corporation’s data integrity & business ethics requirements · Perform other related duties incidental to the work described herein The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified. Required Skills: · Effective leadership, budget forecast and implementation skills · Excellent analytical skills, with the ability to process scientific and medical data · Able to work independently and in teams · Project management abilities including analytical evaluation, organization, delegation, flexible team management, negotiating and resource management skills · Excellent knowledge of statistical programming · Expertise in manipulating and analyzing SAS data · Able to identify data issues, present problems, and implement solutions. · Capable of communicating technical concepts clearly, concisely, and understandably to non-statistical colleagues · Excellent organizational and time management skills, with the ability to multi-task · Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP) · Strong interpersonal communication and presentation skills · Able to effectively collaborate across cross-functional teams Education or Equivalent Experience: · Master’s degree in biostatistics, statistics or other related, scientific field and ten years of relevant professional experience to include supervision and management experience; or an equivalent combination of relevant education and/or experience. A Ph.D. in biostatistics, statistics, or other related, scien ]]>

<![CDATA[A biomedical company is in need of a Biomedical Tech/engineer who can fix, install, and maintain medical equipment. this position requires 2 years experience. salary ranges based on experience from 45k-65k. Interviews will take place until the end of october. please no recruiters!!!]]>

<![CDATA[Purafil, Inc. (www.purafil.com), a subsidiary of Kaydon Corporation, is seeking an entrepreneurial spirit for the position of Technical Services Manager. This person must be able to provide guidance relative to the development, application, manufacture, sale and service of gas-phase air filtration equipment and air monitoring devices. Qualifications: BS Chemical Engineering, Chemistry, Material Sciences or related discipline from an accredited institution and 3-5 years experience in the field of (gas-phase) air filtration technology preferred. Technical marketing experience a plus. Responsibilities: Technical support both internal and external. Develop technical documents for sales and marketing efforts and for publication in Trade and Technical Journals. Evaluate new and/or competitive products and maintain competition database. Participate in government, trade and professional organizations to develop standards and guidelines related to gas-phase air filtration. Ensure compliance with Purafil’s ISO 9001 Quality Operating System. Potential of 20-25% domestic and international travel. Submit resumes to jobs@purafil.com with salary requirements. ]]>

<![CDATA[General Summary This position is responsible for the operation of the Quality Assurance Unit and the management of personnel within the unit. The incumbent is responsible for planning and coordinating the activities necessary to provide management with confidence that the comapnies products and services satisfy quality and regulatory requirements and for reporting the status of such compliance to management on a periodic basis. Key Responsibilities • Manages the quality assurance unit and its personnel, including the establishment of goals, schedules, priorities, staffing, training, and budgets. • Reviews quality assurance unit system and methods on a periodic basis to ensure its efficient operation and its compliance with applicable regulations and standards. • Reviews and disseminates regulatory reference information that may affect the operation of the quality assurance unit or other areas. Position Specific • Reports the status of compliance with applicable regulations and standards that relate to studies, operations, and facilities to management. • Reviews quality assurance unit inspection reports to assess findings, responses, and need for follow-up activities. • Ensures that the Good Laboratory Practice Master Schedule is maintained according to regulations, standards, and procedures. • Serves as a key contact for regulatory inspections and provides input for responses to those regulatory inspections. • Provides project costing estimates and quality assurance unit input for proposals. • Serves as an internal consultant for system validation projects. • Performs audits of subcontractors who provide support for regulated work. • Effectively communicates with Institute personnel, clients, subcontractors, regulatory inspectors, and third party organizations. • Hires, reviews, motivates, and disciplines, as appropriate, quality assurance unit personnel. • Ensures that budgets are realistically established and attained. Requirements/Minimum Qualifications • Bachelor’s degree in relevant discipline • Five years of experience with regulations and standards (i.e., Good Laboratory Practices, Good Manufacturing Practices) • Previous background/experience implementing GLP • Previous training and quality systems development experience • Ability to lead, motivate and discipline staff • Ability to successfully implement business processes • Ability to observe appropriate safety and study requirements by reading, understanding and following Standard Operating Procedures (SOP), Good Laboratory Practice (GLP) requirements and study protocols. ]]>

<![CDATA[Seeking individuals (females and males) who have an Autism Spectrum Disorder diagnosis (autism, High-functioning autism, Asperger’s, PDD-NOS), age 8 to 17, for participation in a research study. You will be paid $50 for helping us. During this study, we will ask you to take some tests involving questions about words, drawing things, putting together puzzles and taking a computer test. We will also measure your body's responses and take pictures of your brain using an MRI machine. While you are in the MRI machine, you will watch short movies and press a button to tell us what you see and hear. We will tell you what you are supposed to do and have you practice before this. If you are interested in hearing more about participating in this study, please contact the Developmental Neuro lab by phone at 404-413-6472 or by email at DevNeuro@gsu.edu. ]]>

<![CDATA[Seeking males age 8 to 17 for participation in a research study. You will be paid $50 for helping us. During this study, we will ask you to take some tests involving questions about words, drawing things, putting together puzzles and taking a computer test. We will also measure your body's responses and take pictures of your brain using an MRI machine. While you are in the MRI machine, you will watch short movies and press a button to tell us what you see and hear. We will tell you what you are supposed to do and have you practice before this. If you are interested in hearing more about participating in this study, please contact the Developmental Neuro lab by phone at 404-413-6472 or by email at DevNeuro@gsu.edu. ]]>

<![CDATA[A worldwide leader for point-of-care blood diagnostic analyzers is seeking to expand their team. Candidate will provide technical support to include development, scale-up and transfer to production. Will be responsible for working independently on new product formulations to include optimizing a product formula that is scalable and cost efficient. Skill requirements: MS degree in Biochemistry or Chemistry, 2-5 years experience in biochemistry research or coating science where he/she has proven understanding of science to include analytical (UV-VIS, NMR, Fluorescence spectroscopy, etc.), formulation and coating characterization. Must have aptitude for math to include statistics and algorithm development. Demonstrated solid academic track record (transcript to be requested). Excellent communication skills required to include providing technical presentations. ]]>

<![CDATA[Need several field technicians for on-going projects. Involves travel to out-of-state work sites for periods of 3-4 weeks. Do not apply unless you are free to travel. All travel expenses paid. Should have a B.S. degree in a science related field, chemistry helpful. Laboratory background helpful. Must have lap-top (for processing field reports and transmitting to office) and cell phone. Start immediately. Contract position.]]>

<![CDATA[We have an exciting career opportunity for an Event Technician with an Arizona-based accredited tissue bank providing cadaver labs and training for physicians all over the country. The Event Technician will travel on a weekly to biweekly basis Thurs-Sat along the east coast to facilitate the labs and work directly with Doctors to ensure that the labs and training sessions run smoothly. This person will also assist with shipping and transporting specimens and must be able to work independently from home and abroad. Qualified candidates must have a Bachelor's Degree in the Sciences and must possess excellent customer-service and communication skills to work directly with medical professionals. Three years of experience in a medical or closely related field are required. If you are ready for a unique and exciting opportunity in the medical field, email your profile for immedate consideration.]]>

<![CDATA[Purpose The purpose of this position is to provide leadership and direction in the development, management, and implementation of sample surveys, statistical and demographic research and scientific activities related to tobacco use and surveillance activities that focus on tobacco-related behavior and attitudes in an international setting. The incumbent has survey research experience and applies expertise in demography, statistics, and epidemiology to the design and implementation of sample surveys in the 16 countries. Incumbent plans, collaborates and facilitates the implementation of tobacco use prevalence and related indicators internationally and works closely with high-ranking members of the Ministries of Health and WHO offices and partners in these countries. Major Duties and Responsibilities 1. Serve as a consultant and an advisor on international data collection projects utilizing sample survey and studies that encompass a wide range of advanced topics including statistical methods, research, and study design. Matters for which consultation is provided include: demography, statistics, survey research, and sociology in the design and development of research and evaluation studies related to both international and domestic activities. 2. Provide consultation to international health and population agencies, such as WHO, national governments, ministries of health, statistics and education, non-governmental organizations and academic institutions to facilitate the implementation of Global Adult Tobacco Survey. The incumbent collaborates internally and externally with public health experts to ensure that valid research findings are disseminated and applied to tobacco control activities. 3. Assist in the writing of comprehensive statistical reports that include analysis, evaluation, and resolutions of tobacco control issues. Collaborate with analysts and statisticians in international settings to develop joint analyses and publications. Give presentations on survey findings and methodological and statistical approaches to working with large data sets at national and international conferences. Prepares statistical reports, graphs, charts, tables, and narrative material to be used in publishing the surveys and results of studies and in giving oral and poster presentations. Qualifications We are looking for an individual with a strong surveillance (e.g., survey statistics, demography, and epidemiology) experience including scientific data analysis and report writing skills. The successful candidate will have a Ph.D. in statistics, biostatistics, demography, epidemiology, public health, or related field with extensive experience (3-5 years) conducting all aspects of household-based survey data collection. Specific experience should include development of sampling frames, management of data collection teams, designing complex population-based samples, management of data entry and quality control staff, and other relevant experience conducting field work in international settings. Additional analytical and technical skills include advanced knowledge of SAS, Stata, Spss, SUDAAN, and other statistical, sampling, data management and data entry software. Foreign language ability, field experience, and handheld data collection experience are desirable. The ideal candidate will also have lived and worked in developing countries and have appreciation of other cultures. The successful candidate will have experience in a role requiring complex internal and external organizations, as well as demonstrated ability to work with efficiency and diplomacy, flexibility and as part of a team effort and ability to travel up to 30% internationally. ]]>

<![CDATA[Analytical Environmental Services, INC., a NELAC Certified growing and successful laboratory,is seeking 2 Environmental Technical Managers. Position Overview The Technical Manager exercises daily supervision of laboratory procedures and reporting of results. Duties: Updates SOPs as required, Maintains Test Codes, Ensures that all employees are properly trained, Reviews and approves revisions to the Quality Assurance Manual, Maintains records of employee training including acceptable performance of IDOCs(Initial Demonstration of Capability), Provides technical assistance in the development of new methods,Provide technical guidance to analytical staff,Assists with internal and external audits,Ensures that appropriate corrective actions are taken to address analysis identified as requiring such actions by internal and external performance audits or procedural audits, Oversees equipment and maintenance repair and Assists General Laboratory Manager in the investigation of new technologies and proposed equipment acquisitions by the laboratory. Other information: ** Schedule is M-F, 8:30AM-5:30PM.; (Average Hours per Week 45-50) ** Opportunity for a performance based salary increase after 90 days ** Salary is negotiable ** Background Check & Drug Test Required ** Seeking someone to fill position As Soon As Possible. Requirements The candidate must have the following: A Bachelors Degree in chemical, environmental, biological or physical sciences or engineering, with at least 24 college semester credit hours in chemistry and at least two years experience in the environmental analysis of representative inorganic and organic analytes for which the laboratory seeks or maintains accreditation. A Master's or Doctoral degree may be substituted for one year of experience. Experience with NELAC and other environmental certification programs and a strong background in analytical testing is preferred. Experience with the following is preferred: Familiararity with the NELAC,North Carolina & South Carolina Environmental Cerification Programs; Environmental Method Development; 5 plus years experience in analytical testing & supervision of various departments(i.e. Metals, Volatiles, Wet Chemistry). ]]>

<![CDATA[PROJECT HYDROGEOLOGIST GeoTrans, Inc., a subsidiary of Tetra Tech, Inc. (NASDQ-TTEK), offers a casual and challenging work environment, competitive salary, training & development, and excellent benefits. The Roswell, GA office is currently seeking a motivated Project Hydrogeologist. Responsibilities: Will provide support for groundwater flow and solute transport modeling projects. Will assist in development of conceptual models, collect and organize data for input to models, construct, calibrate, and execute predictive models. Will assist in report writing and preparation of graphics for reports and presentations. Experience Requirements: 2-5 years performing similar work. Skills Requirements: Must have strong mathematical and analytical skills. Working knowledge of numerical and analytical models, Must have MODFLOW and MT3DMS experience. Ability to effectively apply supporting programs to conceptualize and display data, including Excel, Surfer, GWVistas, GMS, Access. Working knowledge of GIS (especially ArcGIS) and programming (FORTRAN and VB) a plus. Must have excellent written, oral, and organizational skills. Education Requirements: Minimum of BS in Geology, Civil or Environmental Engineering. MS preferred. Should have had courses in geology and/or hydrogeology as well as numerical methods. ]]>

<![CDATA[Seeking someone with 1-2 years of Research Analyst experience to perform historical investigations of hazardous waste sites. Responsibilities include collecting records, conducting interviews, preparing environmental historical reports, and developing work plans/cost proposals. BA/BS degree required. Successful applicants must have excellent written/oral communication skills. Familiar with CERCLA and related environmental regulations a plus. ]]>

<![CDATA[Perform and document vital signs and ECG’s on all study participants per study protocol; assist with the supervision of study participants; assist Clinical Research Coordinators with copying, faxing and other clerical tasks; assist Clinical Research Coordinators with facilitation of study monitoring visits; collect and record study data; transcribe into case report forms and other duties as assigned. Bachelor's degree in a biological / social science field required. A master's degree desired.]]>

<![CDATA[About the Company: Bracy Analytics is a Statistical Analysis Consulting Firm that started in 2003. We provide services in three primary areas: Data Management, SAS Programming, and Statistical Analysis. We also have a product to standardize clinical trials data and produce clinical reports. Bracy Analytics services and products may be provided individually or in combination to meet the specific needs of each client and each project. Summary: We are looking for an Experienced SAS Programmer for our upcoming job opening located in Atlanta, Georgia. Requirements Qualifications and experience: Qualified candidates must possess a B.S./B.A. or M.S. Degree in computer science, mathematics, statistics or related areas of study. In-depth knowledge of SAS programming with at least 2 years of experience in a pharmaceutical and healthcare environment. Strong knowledge of SAS Macro. Please send CV and salary requirement for consideration to courtney@bracy-analytics.com. **PLEASE NO 3rd Party Vendors** Bracy Analytics is an equal opportunity employer; we are not sponsoring Visas at this time. ]]>

<![CDATA[Hair Stylist in training is looking for models from science and biotech fields to build portfolio. Models must be willing to add hair extentions(a service valued at $200). Each model will receive style of choice and disc of pictures. Model is responsible for providing hair. To be considered: send a pic (no need to be a professional picture) and a description of your desired style. ]]>

<![CDATA[Location: Birmingham, AL Title: Quality Assurance Auditor Full time position available in Quality Assurance. BS degree in Biology or a closely related field, and previous experience with Good Laboratory Practice (GLP) Regulations (3 to 5 years) is STRONGLY preferred. GMP is not the same as GLP. This position performs auditing of facilities and studies to GLP regulations; participating in pre-study meetings, audit scheduling, and maintenance of QA files; monitoring non-clinical lab studies for compliance with regulations, standard operating procedures, and study protocols; auditing protocols, data, reports and computer systems for compliance. Must be able to perform work in a BSL-2 and BSL-3 environment. Positive interaction with study personnel and scientists, and generation of accurate audit reports is required. Must be detail oriented and have excellent verbal and written communication skills. Computer literacy is required, along with the ability to work independently and meet deadlines. Position will require fulfillment of immunizations and use of personal protective equipment, including respirator, as appropriate. Experience and familiarity with laboratory instrumentation is helpful. Apply online at <a href="http://www.southernresearch.org" rel="nofollow">http://www.southernresearch.org</a> for position number sr-01960]]>

<![CDATA[Looking for a Validation Engineer with the following qualifications: -Must have Kaye Validator Experience -Experience working with cGMP in a medical device company -Experience writing, executing, and completing validation studies -Mechanical aptitude (ability to assemble equipment correctly, ability to operate equipment) -Experience with Microsoft Excel Behavioral Competency: -Self starter -Great attendance -Analytical skills Degree in Microbiology or similar. -Drive for results *Will be responsible for Validating process and machines. Needs to be mechanically inclined. *6 month+ contract position ]]>

<![CDATA[Looking for a Validation Engineer with the following qualifications: -Experience working with cGMP in a medical device company -Experience writing, executing, and completing validation studies -Mechanical aptitude (ability to assemble equipment correctly, ability to operate equipment) -Experience with Kaye validator -Experience with Microsoft Excel Behavioral Competency: -Self starter -Great attendance -Analytical skills Degree in Microbiology or similar. -Drive for results *Will be responsible for Validating process and machines. Needs to be mechanically inclined. ]]>

<![CDATA[Guide hundreds of students on tours of solar energy, carnivorous plants, nature trails and an organic farm. We also need assistance with other projects ranging from organic farm and greenhouse work, to maintaining nature trails or helping to research and update information on our websites. Depending on the range of responsibilities pay can range from $7.50 to $10.50 per hour with the option of possible healthcare in the future. The Georgia Nature Center is in Oconee County, 20 minutes S of Athens, or 20 min. N of Madison (I-20), and is the largest educational center of its kind in the Southeast. You will guide tours across 100-acres of exhibits and trails including the Clean Energy Exhibition featuring solar & wind power, an organic farm, the Next Generation home, and an endangered plant greenhouse containing thousands of rare carnivorous plants. Large school groups, up to 300 people per day, kindergarten through 12th grade, visit the center regularly, and you will lead groups of them on 2 to 3-hour tours. We usually have tours booked every day, Monday through Friday, and sometimes on Saturdays. We also schedule EcoCamps throughout the year, which last 6-hours per day. Your schedule can be very busy most weeks, though some weeks around holidays, or during the summer, work hours might decrease. A typical work schedule would be 8 a.m. to 3 p.m., 5 or 6 days per week, though hours vary depending on the number of tours booked, and what times of day the tours are scheduled for. You will help setup and tear down items, and help sell educational plants/solar kits in the Nature Center Store to visitors of the center. Please visit <a href="http://www.NatureCenter.com" rel="nofollow">www.NatureCenter.com</a> to learn more about the nature center. You can learn about some of the other related projects you might get involved with on these other websites: <a href="http://www.World.Org" rel="nofollow">www.World.Org</a> and <a href="http://www.RescueMe.Org" rel="nofollow">www.RescueMe.Org</a> IMPORTANT: PLEASE DO NOT CALL OR VISIT IN PERSON. EMAIL A RESUME TO APPLY. Watch your email inbox for a JOB APPLICATION from us within a day or two. If you do not see this email from us within 72 hours, be sure to also check your SPAM and JUNKMAIL folders since sometimes our emails are filed in the wrong place depending on what email program our Internet service you use.]]>

<![CDATA[An Atlanta research office that prides itself on excellence within the clinic, the community, and the pharmaceutical industry is looking for a research coordinator for phase II – IV clinical research studies. At least one year of clinical research experience is preferred. Study subject safety is our priority through routine and acute follow-up. We are compliant with Good Clinical Practices (GCPs), FDA and OSHA regulations, ICH Guidelines and the Declaration of Helsinki. HIPAA compliance and Standard Operating Procedures (SOPs) and policies are in place. The successful candidate has the ability to establish patient relationships, be an effective educator and have clinical skills for direct involvement in patient care. Clinical skills include but are not limited to vital signs, ECG’s, injections, phlebotomy and laboratory specimen collection/shipping, and other specialty procedures. This position includes completion of regulatory documents, Institutional Review Board (IRB) submission and travel to Investigator meetings. You must have the ability to read and understand a protocol, create study-specific source documents, collect accurate data, and follow through with query resolution and/or site audits. Facilitate proper storage of all study products, and maintain accurate drug accountability records for receipt, dispensation and return. You must be able to work independently as well as in a team to develop and implement a plan to optimize recruitment. You must have excellent ability to communicate clearly and effectively in oral and written form to complete work in a timely manner. Computer skills and an aptitude for learning new applications are required. Additional Requirements: Graduate of an accredited school of nursing or related health occupation equivalent with proper certification or licensure. CCRC certification from the Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA) within 3 years of employment. CPR certification. Knowledge of common safety hazards and precautions to establish a safe work environment. IATA shipping certification within 1 month of employment. Maintain CEUs for certifications and registries. Reliable transportation. Fax Resume to 770-817-9201]]>

<![CDATA[Required Experience: • Education: RN, relevant clinical experience or 4 year Life Science degree. • Minimum Work Requirements: 3 years of clinical drug trial field monitoring experience with a pharmaceutical, CRO, or device company. • All Therapeutic areas will be considered. You will go to the front of the line if you have Oncology, Cardiovascular or HIV experience. • Skills: Ability to communicate with professional medical personnel. Understanding of the drug development process. Ability to complete tasks in an accurate and timely manner. • Physical Requirements: Ability to travel an average of 50% and be within one hour of a major airport. Other information: This position is with a large Clinical Research Organization (CRO). It is a home based position. You MUST have the required experience noted above. Please do not email me your CV if you are a lab tech, are not a United States Citizen (Green Cards are fine) or someone who “knows they can do the job”. I am sure you all are great people but I need experienced monitors. ]]>

<![CDATA[Job Description: The responsibility of the CRA I/II is to oversee the conduct of a Pharmaceutical clinical trial to insure the quality and integrity of data and safety and efficacy of the drug. In coordination with the team leader, exercise responsibility for project activities related to monitoring function. Interface with clinical investigators and other site personnel in order to carry out this responsibility. Required Experience: • Education: RN, relevant clinical experience or 4 year Life Science degree. • Minimum Work Requirements: 6 months of clinical drug trial field monitoring experience with a pharmaceutical, CRO, or device company for CRA I. For CRA II you must have at least 2 years experience. • All Therapeutic areas will be considered. You will go to the front of the line if you have Oncology, Cardiovascular or HIV experience. • Skills: Ability to communicate with professional medical personnel. Understanding of the drug development process. Ability to complete tasks in an accurate and timely manner. • Physical Requirements: Ability to travel an average of 75% and be within one hour of a major airport. Other information: This position is with a large Clinical Research Organization (CRO). It is a home based position. You MUST have the required experience noted above. Please do not email me your CV if you are a lab tech, are not a United States Citizen (Green Cards are fine) or someone who “knows they can do the job”. I am sure you all are great people but I need experienced monitors. ]]>

<![CDATA[Quality Control Technician in Food Manufacturing Industry (Cumming) Must possess the following skills: • Experience in monitoring product, production, and sanitation processes • Experience in the Food Manufacturing Industry. • Ability to ensure department objectives are met. • Oversee Production Area, Raw, and Finished Product, Sanitation • Information Reporting, Projects, Human Resources, and Safety. Experience: -minimum of a high school education or GED -Certification or a higher degree in Food Science, Biology, or related field. -1-3 years Quality Control Experience in Food manufacturing industry a MUST -Microsoft Office Or B.S. in Food Science and Technology ]]>

<![CDATA[National A/E consulting firm has an immediate opening for an Industrial Hygiene Technician in our Atlanta office. Ideal candidate should possess current certifications, with a minimum of 1 year experience performing asbestos, mold and lead-based paint projects. Any IAQ experience a plus. EOE]]>

<![CDATA[RESPONSIBILITIES: In this role you will manufacture and oversee production of chemicals through reaction and distillation. Duties include: Follow OSHA and FDA regulations and ensure compliance with recordkeeping. Prepare all departmental documentation including SOP's and device routers (batch records). Prepare purchase orders for materials and ensure inventory levels are adequate to meet production needs. REQUIREMENTS: A four year degree in Chemistry or a related field is required. Knowledge of Polymers, Monomers, and Cyanoacrylates preferred. Knowledge of ISO 13485,cGMP and FDA regulations preferred. Distillation experience. Prior supervisory experience. This is a permanent, strategic role in our organization. We offer an entrepreneurial work environment, competitive salary, and full benefits package including 401(k). ]]>

<![CDATA[Job Summary: Represent the quality of products and services provided by Technology Think Tank, Inc. and Research Think Tank, Inc. Responsible for developing, implementing, documenting, and supervising Quality Systems and Programs which facilitates maintaining the quality and reliability of products and services. Major Duties and Responsibilities: 1. Determining whether finished products and services provided are of a specified quality. 2. Monitor all quality related activities in the laboratories and manufacturing warehouse. 3. Schedule and perform all internal and external audits on behalf of the companies’ management. 4. Verify client quality requirements are specified to vendors and contractor documentation submittals and attend client quality management meetings. 5. Identify cause of product defects and/or services problems to develop methods for reducing their occurrence. 6. Monitor the progress and effectiveness of the quality management system. Recommend and implement improvements when required. 7. Coordinate all QA/QC activities with the clinical laboratory director and the CEO/President. 8. Coordinate all quality related correspondence with the client representatives. 9. Inspect and test products at various stages in the production process. 10. Set up and perform testing on materials, parts, or finished products to measure product performance under a variety of conditions. 11. Responsible for accurate record keeping to gather data and prepare reports regarding the quality and reliability of all products and services. 12. Recommend methods to minimize scrap and/or leftover materials in manufacturing to reduce costs. 13. Coordinate vendor quality approvals, take part in supplier audit and surveillances, and review status of site purchase orders to ensure that all applicable requirements are met. 14. Responsible for preparing, controlling, and distributing companies’ QA manual control and supervise all amendments and revisions. 15. Position may include additional duties as needed as directed by the COO of TTT and CEO of RTT. 16. Develop and support an atmosphere for a teamwork environment and professional conduct. Qualifications: Minimum BS with 3-5 years experience in scientific or reference laboratory setting or M.S. or higher degree in related fields with 1-2 years experience. Background in manufacturing and statistician experience preferred. Strong software/PC skills desired. Good organizational skills. Strong oral and written communication skills. Must be able to deal effectively with company personnel on levels ranging from manufacturing, lab technicians, to top management. Software experience with Macintosh, PowerPoint, Adobe, and Microsoft Office. Work Conditions: Includes working in offices and laboratories. ]]>

<![CDATA[Small food company who has licensed food biotechnology seeks expertise in drafting a report to the industry on the basic principles of the technology. Must be immediately available for this freelance assignment. Will require signing a NDA. Send your resume along with up to 3-samples of your technical writing skills.]]>

<![CDATA[ROLE & RESPONSIBILITIES The Team Leader coordinates workflow and streamlines procedures to ensure efficient and customer-focused operations in the eImaging Department. Ensures reports are processed and records are kept in a timely and confidential manner. • Monitor workflow of the eImaging team and ensure operations are timely and accurate • Coordinate the processing of all reports including Executive clinic and Tech without Professional; finalize reports within prescribed timelines • Maintain efficient processes in reporting and the file room; suggest and implement new processes in collaboration with Clinic Manager • Provide training to employees and provide orientation for new employees • Work with eImaging team to identify performance issues and coach employees; provide input to Clinic Manager regarding team performance evaluations • Collaborate with Radiologists, referring physicians, colleagues and internal and external departments to answer questions and to identify and resolve issues efficiently and effectively • Use and coach other employees on software programs and upgrades including MRIS, PACS and Inteleviewer on a regular basis • Close tills and balance cash and credit card transactions • Perform other duties as required to ensure consistent operations in eImaging • Incumbent may be involved with committee work and projects as required QUALIFICATIONS • 2 years of work experience in sciences setting • Excellent written English and knowledge of medical terminology are essential • Some proficiency with MS Office (Word, Excel, Outlook) and experience with radiology-related software is a definite asset • Experience in coaching/mentoring team members and supervision of staff an asset • Able to take initiative in solving problems relating to missing files/reports, workflow and team issues • Capable of working within a busy environment (400-500 reports are processed daily) • Good communicator, professional, organized individual and able to motivate others. ]]>

<![CDATA[The Director of Telehealth Clinical Services will provide advice regarding clinical content, clinical processes and work flows, and professional practice standards related to telehealth services, chronic disease management and patient self-care coaching. This position requires that you serve as the expert in the monitoring, maintaining and demonstrating of clinical software for clients. Responsibilities generally include but are not limited to: • Direct the Operations of Chronic Disease Management service, including the development and implementation of human resource plans, clinical services, quality management programs and staff development • Serve as the principle liaison with clients who are using any clinical services related to Chronic Disease Management, telehealth or patient self-care. • Ensure that all clinical information is clinically sound and reflects recognized clinical standards and health care practices • Establish and maintain effective relationships health industry stakeholders, including governments, private sector companies, health professional organizations and potential business partners Qualifications: • Degree in sciences or other health-related discipline preferred • Strong English communication skills, both oral and written. • At least 5 years clinical leadership experience with evidence of creative problem solving • Clinical experience and leadership in a telehealth environment and/or clinical expertise caring for people with chronic diseases preferred • Experience working in an interdisciplinary/multi-agency service delivery model We will consider very strong candidate that are coming from field. We offer a competitive compensation and benefits package commensurate with your qualifications. ]]>

<![CDATA[Position Summary: Position will support the design, manufacture and testing of all BioMedical product lines including liquid oxygen reservoir/portable medical devices, concentrators, pulse oximeters, vacuum insulated products for the cryogenic storage of biological materials at low temperatures and accessories. Basic responsibilities include maintenance and organization of the lab and required equipment, manage the equipment calibration system, work with Engineers to perform required product testing/validation, format and write engineering test reports, create laboratory experiments based upon the scientific principles, perform and/or coordinate any preventive maintenance or service on equipment, and work as a liaison between Product Engineering and the Production facilities to assist in resolving issues that arise. Responsibilities: •Product and Component Testing for Validation and Qualification •Assist with development of test plans •Set-up required test equipment and perform testing •Assist Engineering in building prototypes for testing •Communicate results via written reports •Calibration of Lab Equipment •Maintain Marietta Calibration System •Ensure equipment is calibrated as required •Maintain Calibration records •Maintenance of Lab Equipment •Perform preventive maintenance on lab equipment •Coordinate and/or service lab equipment as necessary •Maintain and organize Lab Area and Equipment •Keep lab organized at all times •Ensure tools and equipment are maintained and available for testing •Engineering Liaison between Product Engineering and Production •Work with Engineering and production facilities on design and manufacturing issues •Work with Engineering and Repair Facilities to perform testing on defective product from the field. Skills/Requirements: •Minimum High School graduate •Working knowledge and experience with MS Office (Excel and Word) •Mechanically inclined (skilled with hands) •Good communication skills (written and verbal) •Good problem solving skills •Ability to work with cross-functional teams •Strong organizational skills •Demonstrated ability to plan and manage multiple tasks/projects •Ability to follow the scientific method of experiments]]>

<![CDATA[ Position: Validation Engineer Location: Greater Atlanta Salary: up to $65,000 + 5% bonus Reports to: Validation Manager Relocation: no ABOUT THE COMPANY This company is a contemporary biological medical device company that, since its founding in 1984, has been focused on the development of implantable biological devices, surgical adhesives, and biomaterials for use in cardiac, vascular, and spinal reconstruction for patients of all ages. Employees share a commitment to help improve lives and a commitment to the achievement of excellence. We show our appreciation of our employees' efforts by providing attractive compensation, an excellent benefits package, training and career development opportunities, pleasant and professional work environment, and state-of-the-art facilities. POSITION OVERVIEW The Validation Engineer will utilize quality engineering techniques and practices to ensure that raw materials, components, and products received, processed, and released for distribution by the company. meet or exceed their intended performance requirements for safety and efficacy. RESPONSIBILITIES „X Design, prepare, execute, and analyze installation qualifications (IQs), operational qualifications (OQs), performance qualifications (PQs), and process validations (PVs) to approve equipment, processes, and software used in the testing, processing, storing, and distribution of products. „X Assist in the implementation of corporate policies and procedures relating to quality, project management, process development, and QSR/ISO compliance by establishing procedures and integrated program plans for achieving reliability in accordance with specifications and procedures. „X Assist in managing the calibration program to insure compliance. „X Provide assistance and technical support to all company projects, facilities, and subsidiaries. „X Provide quality engineering support in resolving supplier-related quality issues. „X Collect, statistically analyze, and develop report packages to support all validations/qualifications. „X Develop, conduct, and document qualifications/validations to ensure that the products processed are proven to be reliable, safe, and effective prior to release. „X Assist in the evaluation of product complaints. QUALIFICATIONS „X Minimum of a Bachelor's degree in mechanical, biomedical or bioengineering, or equivalent work experience. „X Minimum of 2 years' hands-on validation experience, preferably in a pharmaceutical, biomedical, or medical device field (FDA regulated industry), with an in-depth knowledge of current Good Manufacturing Practices, Quality System Regulations, and ISO Standards. „X Must have the ability to write and execute test protocols for validating equipment and have had experience doing this. . „X Specific experience required in the areas of sterilization equipment/processes for gamma, ETO and steam, HVAC systems, USP Purified & WFI systems, and Validation Master Planning. „X ASQ CQE certification preferred, not required. Personal computer skills, i.e., word processing, spreadsheets, data analysis. HOURS 8:30 am - 5:30 p.m., Monday through Friday ]]>

<![CDATA[Will work as a member of an R&D product development team. Will perform routine tasks and assist in maintaining lab and pilot equipment and keep records of results in a notebook. Will follow industry guidelines and approved in-house operating procedures for all testing performed. Will assist senior scientists and be involved in highly repetitive work to include predominantly physical property testing. 1st shift hours, Mon-Friday. Skill requirements: At a minimum, high school education or equivalent relevant experience. Candidate who has some college coursework in chemistry preferred. Must have basic laboratory skills to include some familiarity with physical property testing and sample preparation technique in a laboratory environment. A mechanical aptitude for test equipment or machinery operation is preferred. Must be a quick learner and good at taking direction. ]]>

<![CDATA[Business Development Manager/Director Key Responsibilities • Pursue new clients in the Pharmaceutical industry. • Coordinate proposal preparation, presentations, and contract negotiations with potential clients. • Attend internal and external strategic planning, technical and scientific meetings as required. • Represent company to clients in a positive and professional manner. • Meet appropriate metrics related to sales. • Report to management on ongoing sales activities and metrics. • Any other duties as assigned by immediate supervisor. Skills • Excellent interpersonal and negotiation skills. • Proactive personality with excellent communication skills (written, verbal & presentation). • Understanding of Pharmaceutical development process and GMP guidelines. • Good business acumen. • Creative, resourceful, detailed oriented and highly organized. • Demonstrated ability to develop long term relationships with the clients. • Demonstrated industry and business leadership experience. • Proven success in preparing business plans and strategies. • Ability to leverage internal resources across organizational boundaries to meet client needs. • Travel required as needed to meet metrics and maintain client relationships. • Capable of multi-tasking and creativity in a fast paced environment. • Proficiency with Microsoft office Education • BS degree in business or scientific discipline with applicable experience. • MBA preferred Language Skills • English Minimum Work Experience • ***At least 5 years in Pharmaceutical Development industry with Business Development experience. Will not accept resume without cover letter stating salary base range. Will need to relocate to Maryland.*** • Location: Mid Atlantic ]]>