QA Specialist - Batch Record Review
Core
Conduct comprehensive compliance reviews of executed Batch Production Records (BPRs) and manufacturing documentation for investigational medicinal products to ensure cGMP compliance.
Role type
QA Specialist (Batch Record Review)
Builds
Final manufacturing record packages for batch disposition and ERP materials release.
Domain
Biopharmaceuticals / Clinical Manufacturing
Required skills
cGMP compliance knowledge, batch record review, ALCOA++ principles, Good Documentation Practices (GDP), deviation investigation, CAPA management, change control, root cause analysis, ERP materials release, inspection readiness, data integrity
Preferred skills
Experience with cell banking, drug substance, drug product, or medical devices, on-the-floor review experience, cross-functional collaboration, risk assessment
Technologies
ERP systems, electronic records systems
Responsibilities
Perform compliance and accuracy reviews of executed batch records, logbooks, and electronic records; Provide real-time batch review support on the manufacturing floor; Coordinate with Manufacturing, QC, and external CDMOs to resolve documentation issues; Conduct routine periodic reviews of equipment maintenance and calibration logs; Participate in quality events (deviations, investigations, complaints, CAPAs, change controls); Develop and report quality system metrics; Maintain facility inspection readiness.
Seniority
Mid-level (3-5+ years experience)
