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.

Responsibilities

Perform thorough compliance and accuracy reviews of executed batch records, logbooks, and electronic records for internal manufacturing operations, ensuring adherence to ALCOA++ principles, Good Documentation Practices (GDP), internal procedures, and regulatory requirements; Provide Quality support on the floor and perform real-time batch review for internal manufacturing operations; Support batch record reviews for external operations, including MCB/WCB, DS, DP, device assembly, combination products, and labelling and packaging operations; Coordinate with Manufacturing, MSAT, QC, and external CDMO Quality units to resolve comments, request corrections, and track missing documentation, then compile completed Batch Record Review Checklists and final manufacturing record packages for batch disposition; Perform ERP materials release for internal manufacturing and testing operations in compliance with applicable SOPs and cGMP standards; Conduct routine periodic reviews of electronic and paper-based equipment maintenance and calibration logs, providing Quality oversight of QC and Manufacturing operations; Review and participate in quality events such as deviations, investigations, product complaints, CAPAs, and change controls, driving investigation closeouts and root cause determination; Develop and report quality system metrics for review and release activities, and contribute to continuous improvement and risk assessments for manufacturing operations and batch disposition; Maintain facility inspection readiness, escalate risks to site leadership, and support inspections and audits of the clinical manufacturing facility, while staying current on applicable quality and regulatory requirements and trends

Requirements

BSc in a relevant scientific discipline with 5+ years of industry experience, or MSc with 3+ years, in Quality Assurance, Quality Control, or Manufacturing Operations within a cGMP-regulated biopharmaceutical or medical device environment; Direct experience reviewing manufacturing documentation for cell banking, drug substance, drug product, or medical devices/combination products, including on-the-floor review in a manufacturing environment; Thorough understanding of cGMPs and regulatory requirements from Health Canada, the FDA, the EU, and ICH; Strong critical thinking and organizational skills to manage multiple batch reviews at once and meet tight timelines; Exceptional attention to detail and a firm commitment to data integrity and compliance; Strong communication and collaboration skills as part of a cross-functional team in a fast-paced environment

Benefits

6% non-match RRSP contribution; Equity; Annual bonus dependent on individual and company performance; CAD $1,500 annual Active Lifestyle Allowance; Annual vacation; Professional development opportunities; Comprehensive health benefits; Scientific and technical mentorship; Strong sense of community through work, clubs, and socials