Acquire, review, and evaluate material-related cGMP documentation, including Certificates of Analysis (CoAs), specifications, test results, and BSE/TSE statements. Label, release, and track the status of quarantined, released, and rejected materials to support continuous operations.Deliver on-the-floor quality oversight across material receipt, warehousing, gowning qualification, and manufacturing walkthroughs. Uphold Good Documentation Practices (GDP) and execute real-time record reviews on the floor.Assist with archiving completed documentation and managing controlled documents according to internal and regulatory standards. Support document revision workflows concerning disposition, materials, and manufacturing processes. Maintain audit readiness by ensuring records are properly organized, accurate, and readily retrievable for inspections. Maintain compliance with cGMP and ISO guidelines, promptly reporting process deviations, product defects, or regulatory findings. Follow site safety protocols across office, warehouse, and cleanroom environments.
0-1 years
Direct exposure to materials management, raw material disposition, or floor QA support within a biomanufacturing or advanced therapeutics facility. Pre-existing cleanroom gowning qualification. Hands-on familiarity with inspection/audit readiness preparation and electronic document archiving systems.
Education: Bachelor???s degree in a life science or related discipline, or an equivalent combination of education and industry experience. Experience: 0???2 years of cGMP experience within a Quality Assurance setting. Regulatory & Industry Knowledge: Working understanding of cGMP regulations (21 CFR 210/211, EU GMPs, ICH guidelines), quality systems, and supply chain fundamentals. Technical & Software Tools: Proficiency in Microsoft Office applications and Quality Management Systems (QMS).
Bachelors
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