QA Specialist - Batch Record Review

AbCellera seeks a QA Specialist to review batch production records and manufacturing documentation for clinical investigational medicinal products in a cGMP environment. The role involves compliance assessments of internal and contract manufacturing operations across cell banks, drug substance, drug product, and finished formulations.

Responsibilities

• Conduct compliance and accuracy reviews of executed batch records, logbooks, and electronic records against ALCOA++ and GDP standards
• Provide real-time quality support and batch review during internal manufacturing operations
• Support batch record reviews for external operations including cell banks, drug substance, drug product, and combination products
• Coordinate with Manufacturing, QC, and CDMO Quality units to resolve comments and compile final batch record review packages
• Review equipment maintenance and calibration logs; participate in deviations, investigations, complaints, CAPAs, and change controls

Requirements

• BSc in relevant scientific discipline with 5+ years QA/QC/manufacturing experience, or MSc with 3+ years
• Direct experience reviewing manufacturing documentation for cell banking, drug substance, drug product, or medical devices
• Thorough knowledge of cGMP regulations and Health Canada, FDA, EU, and ICH requirements
• Strong critical thinking and organizational skills to manage multiple concurrent batch reviews
• Exceptional attention to detail and commitment to data integrity
• On-the-floor manufacturing review experience in cGMP-regulated environment