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 are looking for an enthusiastic QA for QC Specialist to join our Quality Assurance Operations team and help ensure the quality and compliance of the data behind our biologics clinical manufacturing. In this role, you'll review and disposition the data generated from the cGMP Quality Control (QC) labs, which support our state-of-the-art biologics drug substance clinical manufacturing facility. As the QA partner for QC, you’ll oversee laboratory activities and help make sure our processes and procedures meet the highest standards of quality and compliance. If you’re a detail-driven QA professional who wants to play a hands-on role in bringing clinical-stage therapies to patients, we’d love to hear from you How you might spend your days Developing and supporting departmental processes, procedures, documents, and records for QA of QC-related operations Reviewing manual and electronic data from the testing of incoming materials and components, environmental monitoring and clean utilities, in-process bulk DS/DP, FDP, stability programs, retention/reference samples, reference standards, and cell banking activities Approving protocols and reports for QC equipment and instrument qualification and validation, method transfers, and method verification/qualification/validation, along with ongoing monitoring reports such as EM and utility trending, APQRs, and QC method monitoring Documenting and escalating QC data issues, including errors, inconsistencies, non-compliance, and suspected or confirmed OOT/OOS results, and dispositioning QC data generated during investigations and product complaint investigations Participating in quality events such as deviations, CAPAs, and change controls to drive closeouts and root c…
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