batch-record-review jobs in San Diego

Associate Director of Technical Operations at a biopharmaceutical company overseeing CMC (Chemistry, Manufacturing, and Controls) strategy for a diverse portfolio of small-molecule drugs in development through commercialization. Leads external manufacturing partners (CMOs), manages technology transfer and scale-up activities, ensures cGMP compliance, and authors regulatory submissions.…See more Requires 8+ years of progressive CMC and drug development experience with demonstrated leadership across multiple CMC disciplines and small-molecule, peptide, and biologic manufacturing.

The QA Associate II reviews manufacturing batch records, analytical test results, and quality documentation to ensure compliance with cGMP and company procedures. Responsibilities include assessing deviations and CAPAs, conducting line clearance inspections and process observations, supporting material and equipment qualification, and participating in audits and investigations.…See more The role requires judgment in routine and moderately complex quality decisions, cross-functional collaboration, and SOP documentation in a regulated biopharmaceutical manufacturing environment.

This Quality Assurance Specialist II role supports clinical trial projects at a pharmaceutical CDMO, ensuring compliance with cGMP and SOPs throughout the product lifecycle. Responsibilities include pre- and post-execution batch record review, authoring/updating QA and compliance documentation, participating in investigations and deviation writing, and reviewing change controls.…See more The candidate must demonstrate strong knowledge of GMP environments, proficiency with MS Office (especially Excel) and ERP systems like JD Edwards, and 5–10+ years of relevant pharmaceutical QA experience depending on education level.