The Batch Record Reviewer supports clinical biologics manufacturing by performing operational review of executed batch records and ensuring documentation meets ALCOA+ , GDP , and GMP expectations. As part of the Manufacturing Operational Excellence team, this role focuses on right‑first‑time execution , documentation robustness , and efficient lifecycle management across both paper‑based and Electronic Batch Records (EBR) .

The position works closely with shop‑floor teams, manufacturing SMEs, and Quality, while remaining fully embedded within Manufacturing Operations.

Key Responsibilities

1. Executed Batch Record Review

• Perform operational review of executed batch records for clinical biologics manufacturing, including:
• Upstream Processing (USP)
• Downstream Processing (DSP)
• Weighing & Dispense (W&D)
• ...