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company in Vancouver, Canada
QA Specialist at AbCellera (Vancouver) performs cGMP compliance and accuracy reviews of executed Batch Production Records, logbooks, and electronic records for clinical antibody-drug batches made in-house and at CDMOs, supporting batch disposition. Core work involves GDP/ALCOA++ documentation review, ERP materials release, quality events (deviations, CAPAs), and inspection readiness.
A 15-month contract QA Operations Specialist at a clinical-stage biotech in Vancouver: you review GMP batch records, raw data, and quality events (deviations, CAPAs, change controls), release materials in the ERP, and support audits and inspections to keep clinical manufacturing cGMP-compliant and inspection-ready.
AbCellera is hiring an External QA Specialist/Manager in Vancouver to oversee the quality of contract manufacturers (CMOs) producing its monoclonal antibody drugs — handling supplier qualification, quality agreements, batch record review/disposition, GMP audits, and inspection readiness. Core focus is biopharma cGMP quality management using eQMS/enterprise tools like Veeva and SAP.
QA Specialist on AbCellera's Supplier Quality Management team overseeing the full supplier lifecycle — selection, qualification, quality agreements, deviations, risk assessments, and audit readiness — for materials and services supporting monoclonal antibody programs. Requires QA experience in regulated biopharma, cGMP knowledge, and eQMS/ERP tools like Veeva and SAP.