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Overview Performs any basic to complex Analytical assay(s) according to and in compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs.
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Support tech transfer of new methods from analytical development and contract laboratories to the Quality Control Laboratory. A minimum of 10 years in similar cGMP environments with broad knowledge of Quality Control procedures, bioanalytical, chemistry, microbiology assays for sterility, endotoxin, TOC, and stability programs required for biologic therapies.
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Under supervision and guidance, the Process Associate I will be responsible for hand-on executing the routine operation and periodically commissioning/startup of media/buffer/washer/autoclave equipment and production suites in a cGMP biopharmaceutical pilot plant.
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Familiarity with cGMP Quality Control Testing, Qualification, and validation of analytical test methods compliant to Good Laboratory and Documentation Practices. Manage the analytical testing of products (in-process, for information, and release) Review the testing schedule with the QC Supervisor Perform day to day analytical testing activities in GMP QC lab to support the on-time release and periodic testing of biological drug products using complex instrumentation and laboratory equipment’s per regulatory/quality policies.
$150,000 - $190,000 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Learn and maintain thorough familiarity and compliance with all state and federal regulations, U.S. Food and Drug Administration (FDA)-approved Standard Operating Procedure Manual, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), Current Good Manufacturing Practice (cGMP) and internal company procedures.
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JOB DESCRIPTION ACTALENT IS SEEKING QC SCIENTISTS FOR A PHARMACEUITCAL R+D FACILITY IN WESTON, FLDescription:•Conduct standard and advanced laboratory activities with minimal supervision including for example analyzing raw materials, in-process materials and finished pharmaceutical products for quality, safety, purity, strength and identity using applicable methods or manufacturing drug product, following cGMP, EH&S and other relevant guidelines of Corporate, FDA and other governing bodies.
$43.27 - $48.08 an hourExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Previous experience with Laboratory IT systems such as LIMs, LES, and MODA. Additional Preferences: Experience with cGMP requirements and regulatory compliance associated with a cGMP Manufacturing facility.
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Transfer of test protocols from Analytical development lab (or clients) to cGMP compliant QC laboratory. Bachelor's degree in Biological Sciences, Virology, Microbiology, Biotechnology or related field with minimum 3 years related experience in regulated laboratory environment.
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Have prior experience in a cGMP laboratory. Qualifications: Hold a Bachelor’s degree in biotechnology, biochemistry, chemistry, or a related field with a minimum of 5 years of experience in a pharmaceutical/biotech QC laboratory.
$33.5 an hourFull-timeExpandUpdated 3 days ago - UpvoteDownvoteShare Job
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Supervise donor selection, plasma collection and all manufacturing records to maintain the highest production standards in accordance with Federal and State regulations, with FDA approved Standard Operating Procedure Manual, OSHA, CLIA and cGMP.
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Bachelor’s degree in Science or Engineering or relevant field with at least 1 year Biotech/Pharma bioprocess experience (upstream and/or downstream), preferably in a cGMP setting. Experience with production equipment such as: centrifuges, single use bioreactors, depth filters, chromatography skids, incubators, tube welders and other common laboratory/cleanroom equipment.
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The incumbent may also support other microbiological test methods, equipment and laboratory support and maintenance, and assist with the drafting of SOPs, protocols and reports to support cell therapy manufacturing operations.
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Serve as mentor to Quality Laboratory Associate (QLA) I and II positions. Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.
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Quality Assurance responsibilities include, but are not limited to, cGMP documentation review related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production and process controls.
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Bristol-Myers Squibb is seeking a quality control professional to join our QC Incoming Materials team, performing QC testing in on raw materials in support of biologics bulk drug substance manufacturing using defined methods in a cGMP compliant laboratory.
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