QA Specialist - Batch Record Review

Each of us cares about someone who will need medicines. That’s why our vision is to repeatedly beat the odds to deliver breakthrough medicines to patients who need them. We pursue truth and scientific rigour and have the courage to work at the edge of the unknown. We're looking for an enthusiastic QA Specialist to join our Quality Assurance team and help ensure our clinical batches meet the highest standards of cGMP compliance. In this role, you'll conduct comprehensive compliance reviews of executed Batch Production Records (BPRs) and related manufacturing documentation for batches made internally and through Contract Development and Manufacturing Organizations (CDMOs). You'll directly support investigational medicinal products (IMPs) at every stage of development, including Master/Working Cell Banks (MCB/WCB), Bulk Drug Substance (DS), Drug Product (DP), Finished Drug Product (FDP), devices, and combination products. If you're a detail-driven QA professional who wants your reviews to help get clinical programs to the patients who need them, we'd love to hear from you. How you might spend your days Performing thorough compliance and accuracy reviews of executed batch records, logbooks, and electronic records for internal manufacturing operations, ensuring entries adhere to ALCOA++ principles, Good Documentation Practices (GDP), internal procedures, and regulatory requirements Providing Quality support on the floor and performing real-time batch review for internal manufacturing operations Supporting batch record reviews for external operations, including MCB/WCB, DS, DP, device assembly, combination products, and labelling and packaging operations Coordinating with Manufacturing, MSAT, QC, and external CDMO Quality units to resolve comments, request corrections, and track missing documentation, then compiling the completed Batch Record Review Checklists and final manufacturing record package for the authorized person's batch disposition Performing ERP materials release for internal manufacturing and testing operations in compliance with applicable SOPs and cGMP standards Conducting routine periodic reviews of electronic and paper-based equipment maintenance and calibration logs, providing Quality oversight of QC and Manufacturing operations Reviewing and participating in quality events such as deviations, investigations, product complaints, CAPAs, and change controls, driving investigation closeouts, and root cause determination Developing and reporting quality system metrics for review and release activities, and contributing to continuous improvement and risk assessments (evaluation, mitigation, documentation, and reporting) for manufacturing operations and batch disposition Maintaining facility inspection readiness, escalating risks to site leadership, and supporting inspections and audits of the clinical manufacturing facility, while staying current on applicable quality and regulatory requirements and trends We’d…