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5 years minimum experience in managing facilities for a cGMP FDA regulated pharmaceutical manufacturing environment; 2 or more year aseptic processing facility preferred. · (For example: OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.
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Compliance with all regulatory requirements, including FDA, cGMP, and other industry standards. Strong knowledge of FDA regulations, cGMP, and other. We hold the distinguished position of being the largest 503A compounding pharmacy and FDregistered 503B outsourcing facility in the country serving the functional medicine markets.
Full-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Compliance Adherence: Ensure strict site adherence to regulatory requirements, including implementing SOP's, US FDA Good Laboratory Practices (GLP), and current Good Manufacturing Practices (cGMP) under preclinical to clinical grade testing.
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Familiarity with cGMP, FDA, and guidelines governing medical devices. Create and process change packages which include performing document searches and creating redline documents. Job Title Manager, Quality Systems – Document Control FLSA Status Exempt Position Summary The Manager, Quality Systems – Document Control reports directly to Senior Manager, Document Control and Training.
Full-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Experience within cGMP/FDA regulated industry. Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique. Production of blood component lots through cell culture, harvest, and cryopreservation.
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Some technical writing skill set and be able to critically review documents while effectively inputting and expressing Quality principles Position Reports to Jenna Walker – Associate Director, QA Training & Document Control Education: Bachelor’s degree or equivalent Key Requirements and Technology Experience: Minimum of 1 year of relevant document control experience in a cGMP/FDA regulated environment.
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Direct cGMP related experience required for FDA / EMA regulated environments. 5 years in BioPharma/Cell and Gene Therapy Industry experience. Clear technical experience in design and operation of cell and gene therapy.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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As a Microbiologist you will apply cGLP, cGMP, ANSI, AAMI, ISO, EUMDR, FDA and USP guidelines to the bioburden, cytotoxicity, bacterial endotoxin, and biocompatibility analysis of orthopaedic implants and surgical instruments for Leesburg, VA facility.
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Develop validation documents per FDA cGMP and GAMP standards, functional specifications, design specifications and requirements trace matrices. Prepare and execute validation protocols (AIQ, IQ, OQ) for 21 CFR Part 11 compliance per FDA requirements.
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The Quality Assurance Manager will ensure compliance with current Good Manufacturing Practices (cGMP) as they pertain to the local regulation and exporting countries regulation as applicable (such as FDA, MHRA, EMA, Health Canada.
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Selection of suitable plasmapheresis donors by performing physical examinations and taking medical histories on all donors through the use of FDA approved Standard Operating Procedure (SOP) Manual, current State and Federal guidelines, OSHA, CLIA, CGMP, all internal company procedures and personal education and experience.
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A Minimum of 0-2+ years Biotech/Pharmaceutical experience or equivalent industry experience Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices.
Full-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Demonstrated work experience in compliance with cGMP and FDA requirements, including Good Documentation Practices (GDP). This position is for a major pharmaceutical company , and this position is a suitable for someone with an associate or bachelor’s degree, with 2-5 years of experience in calibration, maintenance, repair, and performance verification work.
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Performs other duties as assigned •Adheres to all applicable procedures, cGMP's, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc. Transport full pallets of finished goods to storage and staging areas with power and pallet jacks in a timely manner, observing all safety regulations and ensuring all cGMP and quality standards are met.
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Issues reports and documentation in accordance with established procedures on a variety of quality system programs related to QSR (CGMP) and ISO requirements. + Ability to understand and follow FDA regulations, ISO requirements, and BD Quality Systems.
ExpandApply NowActive JobUpdated 9 days ago
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