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PBF is a one-of-a-kind cGMP-compliant pharmaceutical manufacturing facility engaging in next-generation development for cutting-edge companies and government agencies. Our core practice areas include vaccine research, development, and production; microbiology and infectious disease research; biodefense; clinical research; global health security; and HIV/AIDS programs.
$101,383 - $124,846 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Document control, archive, archival, archivist, doc control, qa, quality assurance, quality associate, quality specialist, quality assurance specialist, gmp, cgmp, gxp, mastercontrol, veeva vault, edms, document management system, pharma, biopharma, medical device, biotech, biotechnology, fda, quality systems, qms, eqms, clinical manufacturing, commercial manufacturing, novel pharmaceutical, novel drug, novel therapeutic.
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This role will also support monitoring & maintaining all base utilities, buildings, electrical systems, water systems (incoming, pure, and waste) steam systems, HVAC & Refrigeration, Life Safety Systems, and grounds as necessary in a cGMP facility.
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Experience or shown understanding of current Good Manufacturing Practices (cGMP), 21CFR Part 11 regulations, change control, validation. Knowledgeable of Generative AI Technologies for Machine Learning and Natural Language Processing (NLP) and Natural Generation Language (NLG.
$108,811 - $133,653 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API.
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Working knowledge of industry guidelines including cGMP, regulatory guidelines (i.e.: FDA, EU, ICH, ISO), and handling of regulatory inspections. The right candidate has experience in Biotech/Pharma cGMP with an emphasis in a regulated training environment as this role supports the development of the Training program for purposes of compliance.
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Conduct clinical research studies involving administration of investigational products according to the principles of current Good Clinical Practices (cGCP), Good Laboratory Practices (cGLP), and Good Manufacturing Practices (cGMP) and in accordance with all relevant host nation, US Federal, Department of Defense (DoD) and Army regulations and policies.
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Job Overview: A law firm in Washington, D.C., is seeking an FDA - Health Care Associate Attorney with 4-6 years of experience and a strong background in drug and medical device regulatory compliance issues, particularly in current good manufacturing practice (CGMP) matters.
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Maintain compliance with SOP, current Good Manufacturing Procedures (cGMP) and regulatory guidelines. Bachelor's degree with a major in medical technology or one of the biological, physical or chemical sciences plus at least 6 years' experience in acceptable clinical laboratory.
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0-2+ years cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish.
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6+ years cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, and bulk formulation. Coordinate daily operations and lead on the floor manufacturing employees to complete production activities safely and compliantly in accordance with OSHA and cGMP guidelines.
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Write and revise cGMP documents related to technology transfer and production and materials management (SOP’s, MBR’s, DR’s, etc.,) Maintenance of cGMP manufacturing facility, including equipment and manufacturing rooms.
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The role requires knowledge and understanding ofscientific concepts, practices and procedures within the biopharmaceutical field and a cGMP environment. The QC Analyst II, position supports the Quality Control group at Rockville Campus.
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Establish and publish Key Performance Indicators (KPI) to track cGMP compliance for stability studies and sample management. Provide hands-on leadership for the QC Sample Management operations; management of daily/weekly/monthly activities of staff and operational oversight of group, data review, schedule, and training.
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The role requires knowledge and experience of scientific concepts, practices, and procedures within the biopharmaceutical field and a cGMP environment. 1-3 years of relevant experience working in a Quality Control work environment, preferably in the pharmaceutical industry with knowledge of cGMP is a plus.
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cgmp job in Silver Spring, MD
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