The GMP Documentation Specialist supports clinical biologics manufacturing by performing operational review of executed batch records and ensuring documentation supports ALCOA+ standards and GMP expectations.

The role is part of the Operational Excellence team within Manufacturing Operations and focuses on right‑first‑time execution, documentation robustness, and efficient record lifecycle management across paper‑based batch records and Electronic Batch Records (EBR).

This position works closely with shop floor teams, manufacturing SMEs, and Quality while remaining fully embedded in Manufacturing.

Key Responsibilities

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)
• Review paper‑based batch records and EBR for alcoa+, data integrity...