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You will have demonstrated experience, leadership, and independence with QC functions associated with the GMP production and testing of cell/gene therapy products or biologics in both clinical and/or commercial settings.
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Expected to adhere to safe work practices, follow GMP and HACCP guidelines, maintain sanitary conditions and ensure that product quality is maintained. Experience with SQF, ISO, GMP, ASQ, HACCP, PCQI or similar certification experience preferred.
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ADDITIONAL SKILLS: Laboratory, Maintenance, Method Validation, GMP, QA, Radioactive, SOPs, Validation Protocols, Analytical Assays, Bioassay, Biochemistry, Cellular, Cellular Biology, Immunology, Operations, Good Documentation Practices.
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Manage and perform document controller responsibilities through the Electronic Quality Management System. Assist the Quality Manager in the implementation of HACCP, allergen, sanitization, and other programs of the Quality Management System.
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The Quality Assurance Manager will manage the quality assurance, food safety, GMP, supplier audit program and pest control functions at the Indianapolis Plant to ensure products and critical manufacturing supplies meet all applicable government, customer, and company expectations for quality and safety.
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Strong experience in GMP quality systems, including deviation root cause analysis tools. Partner with Quality to maintain a robust quality and compliance culture and performance that meets applicable GMP regulatory standards and supports regulatory inspections.
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Earplugs, hairnets and steel-toed shoes are required per company and plant GMP and Safety requirements. The analyst position is key in maintaining the quality of incoming ingredients, in line product, and finished product.
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Job Title: Senior Director, GMP Quality Assurance, Late-Stage Development. Are you an experienced GMP Quality Leader who's eager to apply late-stage expertise in a mission-driven organization.
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Experience in GMP quality systems and/or manufacturing operations, processes and equipment for US, DS, and/or FF areas. REGENXBIO is seeking a highly motivated Upstream Manufacturing contractor to establish REGENXBIO's 1 internal GMP BDS and FDP clinical and commercial AAV gene therapy manufacturing capability.
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The Associate Scientist II is responsible for direct support of the shipping/receiving logistics, sample oversight and inventory managment function for GMP release and stability testing activities within Clinical Quality Control for Alexion| AstraZeneca Rare Disease biotherapeutic candidates.
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The manufacturing of oligonucleotide APIs in a GMP environment. Work with Manufacturing Management and Quality to resolve manufacturing problems including drafting quality documentation (CAPA, deviation, change control, etc.
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Perform routine ICP-MS and ICP-OES analysis for trace metals in a GMP analytical laboratory. Relevant experience in good laboratory/manufacturing practices (GLP/cGMP), laboratory quality control or stability, and interaction with quality assurance is required.
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Oversee employee training on HACCP, allergen control, GMP, and food security. Ensure FDA, GMP, USDA, and SQF compliance and lead yearly reviews. Maintain processing instructions for product quality and safety, including allergen management.
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As a member of the T. Marzetti Company, completes his/her Behavior Based Quality observations (BBQs), corrects issues when identified and participates in problem solving. SLIP-RESISTANT/Steel-toed SHOES, Earplugs, safety glasses, hairnets, beard nets (if facial hair exists) are required to be worn/used in accordance with company GMP and Safety standards.
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Ensures receiving, storage and usage procedures of production materials or supplies are completed in compliance with Good Manufacturing Practices (GMP) and Safe Quality Food (SQF). DIRECT REPORTS: Material Scheduling Manager, Production Manager, Safety Coordinator, Quality Supervisor, Process Engineer, Maintenance Manager.
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