abcellera · Vancouver
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. How you might spend your days 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…
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