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
External QA Specialist/Manager
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 (Specialist) or 8+ years (Manager) in a regulated life sciences environment, including external biologics manufacturing. They need deep knowledge of global cGMPs, strong eQMS and SAP or Veeva skills, and excellent attention to detail and communication.
Veeva, SAP
Director, Combination Products & Device Development
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 a bachelor's or graduate degree in mechanical, biomedical or chemical engineering, at least 15 years of hands-on device engineering, and deep knowledge of FDA and ISO combination product standards. Management of technical teams and external partners is essential.
Leadership, Regulatory compliance, Coaching, Process improvement, Documentation, Risk management