QA Specialist - Supplier Quality
Vancouver, BCAbCellera: AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology,…
5+ ansCandidates need a relevant science bachelor's degree and 5+ years of QA experience in a regulated life sciences setting (or a master's with 3+ years). They must know supplier quality management, global cGMP and regulatory requirements, and electronic QMS and ERP systems such as Veeva and SAP.
Veeva, SAP
QA Specialist - Batch Record Review
Vancouver, BCAbCellera: AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology,…
5+ ansCandidates need a BSc in a relevant science with 5+ years of industry experience, or an MSc with 3+ years, in QA, QC or manufacturing in a cGMP-regulated environment. They need hands-on batch record review experience, knowledge of Health Canada, FDA, EU and ICH cGMP requirements, and strong attention to detail.
ERP system
QA for QC Specialist (15-month contract)
Vancouver, BCAbCellera: AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology,…
5+ ansCandidates need a BSc in a relevant science with 5+ years of industry experience, or an MSc with 3+ years. They must know cGMP, Health Canada, FDA, EU and ICH requirements and have a strong eye for data integrity.
QC instrumentation
Director, DP MSAT
Vancouver, BCAbCellera: AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology,…
15+ ansCandidates need 15+ years in drug product development and manufacturing of monoclonal or bispecific antibodies, plus a science or engineering bachelor's degree. They need deep knowledge of GMP, aseptic fill-finish for vials and prefilled syringes, and proven CDMO management experience.
Documentation, Procurement, Manufacturing processes, DP, Define technical requirements, Presentation skills