Specialist Quality Assurance - Drug Substance

We are seeking a Specialist Quality Assurance to provide on-the-floor Plant Quality Assurance (PQA) support for Drug Substance operations at a biopharmaceutical manufacturing site in Juncos, Puerto Rico. This role ensures that manufacturing processes, records and changes meet cGMP requirements and site procedures, and partners closely with Manufacturing, Process Development, Validation, Quality Control and Engineering.

Key Responsibilities

• Perform on-the-floor PQA review, approval and tracking of cGMP processes, procedures, documents and records, including batch record review in MES/EBR, SAP and electronic quality systems.
• Ensure on-the-floor triage of deviations is completed and documented, and that deviations are investigated per procedure.