QA Operations Specialist

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 Operations Specialist to join our Quality Assurance Operations team on a 15-month contract and help ensure our clinical batches meet cGMP standards. In this role, you'll support the compliance of our manufactured and tested clinical batches by authoring, reviewing, and maintaining the documentation behind our drug manufacturing and testing activities, all in line with Good Documentation Practices (GDP).

Your work will keep our records accurate, complete, and inspection-ready. If you're a detail-driven QA professional looking for hands-on experience in a fast-moving clinical-stage environment, we'd love to hear from you.

• Providing Quality support for GMP Quality Control and Drug Substance (DS) manufacturing operations, including on-the-floor support and real-time batch review
• Reviewing GMP documents and raw data, including executed analytical and batch records in paper and electronic form, for compliance with applicable procedures and data integrity standards to support the disposition of clinical batches
• Supporting the review of batch records from external operations, including DS, DP, FDP assembly, and labelling and packaging for drug, device, and combination products
• Performing ERP materials release for internal manufacturing and testing operations according to the release schedule, supporting on-time manufacturing
• Supporting the development, implementation, and revision of quality procedures, systems, and manufacturing and testing documentation to maintain compliance and oversight of QC and Manufacturing operations
• Reviewing and participating in quality events such as deviations, investigations (including product complaints), CAPAs, and change controls, driving closeouts and root cause determination
• Participating in risk assessments for manufacturing operations, including evaluation, mitigation, documentation, and reporting
• Maintaining facility inspection readiness, escalating risks to site leadership, and supporting inspections and audits of the clinical manufacturing facility
• Staying current on applicable quality and regulatory requirements and evolving trends
• Supporting and performing internal audits to ensure compliance with cGMP standards and internal procedures

• You have a BSc in a relevant scientific discipline with 5+ years of industry experience, or an MSc with 3+ years, with a strong background in analytical sciences, quality control, or manufacturing of biologically derived drug products
• You have experience in a fast-paced environment ensuring timely review of QC tests, procedures, batch documentation, logbooks, deviations, CAPAs, and change controls
• You have a thorough understanding of cGMPs and regulatory requirements from Health Canada, the FDA, the EU, and ICH
• You bring exceptional attention to detail and a firm commitment to data integrity and compliance
• You communicate well and collaborate effectively as part of a cross-functional team

AbCellera’s hiring range for this role is CAD $82,000 - $102,000 annually, commensurate with your education and job-related knowledge, skills, and experience. In addition to base salary, we offer an annual bonus dependent on individual and company performance and a 6% (non-match) RRSP contribution.

You will have a CAD $1,500 annual Active Lifestyle Allowance, annual vacation, professional development opportunities, and comprehensive health benefits. Scientific and technical…