QA Operations Specialist (15-month contract)

The role

The QA Operations Specialist will support the compliance of manufactured and tested clinical batches. This involves authoring, reviewing, and maintaining documentation for drug manufacturing and testing activities in line with Good Documentation Practices.

What you will do

• Providing Quality support for GMP Quality Control and Drug Substance manufacturing operations
• Reviewing GMP documents and raw data for compliance with procedures and data integrity standards
• Supporting the review of batch records from external operations
• Performing ERP materials release for internal manufacturing and testing operations
• Supporting the development, implementation, and revision of quality procedures, systems, and documentation
• Reviewing and participating in quality events such as deviations, investigations, CAPAs, and change controls
• Participating in risk assessments for manufacturing operations
• Maintaining facility inspection readiness and supporting inspections and audits
• Staying current on applicable quality and regulatory requirements
• Supporting and performing internal audits

Required qualifications

• BSc in a relevant scientific discipline with 5+ years of industry experience, or an MSc with 3+ years
• Strong background in analytical sciences, quality control, or manufacturing of biologically derived drug products
• Experience in a fast-paced environment ensuring timely review of QC tests, procedures, batch documentation, logbooks, deviations, CAPAs, and change controls
• Thorough understanding of cGMPs and regulatory requirements from Health Canada, the FDA, the EU, and ICH
• Exceptional attention to detail
• Firm commitment to data integrity and compliance
• Ability to communicate well and collaborate effectively as part of a cross-functional team

Benefits

• Annual bonus dependent on individual and company performance
• 6% (non-match) RRSP contribution
• CAD $1,500 annual Active Lifestyle Allowance
• Annual vacation
• Professional development opportunities
• Comprehensive health benefits
• Scientific and technical mentorship

About the company

AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology, women’s health, immunology, and oncology.