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QA Auditing Reviewer

Amneal Pharmaceuticals
September 01, 2026
Full-time
On-site
Piscataway, NJ
Operations
Role: QA Auditing Reviewer responsible for auditing production records, determining batch disposition, and executing decisions such as release, hold, or reject, with system updates in JDE and database loading. Responsibilities: thoroughly audit work orders for commercial and exhibit batches, ensure proper storage of held/rejected batches, log RFT data, and occasionally fill in for in-process QA inspectors. Requirements: High School or GED; 2+ years in pharmaceutical QA, QC, or QM; strong knowledge of manufacturing processes and GMP standards including 21 CFR Parts 210, 211, 820, and ICH guidance. Preferred: Bachelor's degree in a related field. HighValue: focus on pharmaceutical manufacturing processes, batch disposition, GMP compliance, and system documentation. WorkSetup: not specified; emphasis on compliance and accurate record-keeping.