Description

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.

Key Skills

Education

Any Graduate