You provide QA oversight and operational support within clinical and commercial manufacturing and testing laboratories.
Responsibilities
Provide on-the-floor QA oversight to ensure continuous GMP compliance throughout the manufacturing area.
Manage the timely issuance of production records and labels while supporting manufacturing production issues.
Compile and verify batch-related documents into Final Product lot disposition packages and approve executed Manufacturing Production Records.
Perform quality investigations regarding manufacturing deviations, non-conforming materials, and CAPA.
Elevate issues affecting lot production or release to management immediately.
Required Skills
2-4 years of experience in Quality Assurance, Quality Control, or a GMP-related field within biotechnology, biologics, or pharmaceutical manufacturing.
Working knowledge of GMP, quality systems, and regulatory requirements including 21 CFR Part 11, 210, 211, 600, and 610.
Experience identifying deviations and managing CAPA.
Knowledge of relevant ICH and FDA guidance documents.
General knowledge of aseptic manufacturing processes.
Proficiency in MS Word, Excel, and PowerPoint.
Bachelor's degree in a technical discipline such as Biology, Chemistry, Microbiology, or Engineering.
Preferred Skills
Experience with cell therapy manufacturing and ASQ certification.
Experience with internal/external audits, Health Authority Regulations, and IQ/OQ/PQ validation practices.