QA Specialist - Batch Record Review

The role

You will conduct compliance reviews of executed Batch Production Records and manufacturing documentation for internal and CDMO operations. You will support investigational medicinal products at every stage of development and provide quality oversight for manufacturing operations.

What you will do

• Performing compliance and accuracy reviews of executed batch records, logbooks, and electronic records
• Providing Quality support on the floor and performing real-time batch review
• Supporting batch record reviews for external operations
• Coordinating with Manufacturing, MSAT, QC, and external CDMO Quality units to resolve comments and track documentation
• Performing ERP materials release for internal manufacturing and testing operations
• Conducting routine periodic reviews of equipment maintenance and calibration logs
• Reviewing and participating in quality events such as deviations, investigations, product complaints, CAPAs, and change controls
• Developing and reporting quality system metrics and contributing to continuous improvement and risk assessments
• Maintaining facility inspection readiness and supporting inspections and audits

Required qualifications

• BSc in a relevant scientific discipline with 5+ years of industry experience, or an MSc with 3+ years, in Quality Assurance, Quality Control, or Manufacturing Operations within a cGMP-regulated biopha
• Direct experience reviewing manufacturing documentation for cell banking, drug substance, drug product, or medical devices/combination products
• On-the-floor review experience in a manufacturing environment
• Thorough understanding of cGMPs and regulatory requirements from Health Canada, the FDA, the EU, and ICH
• Strong critical thinking and organizational skills
• Exceptional attention to detail
• Commitment to data integrity and compliance
• Ability to communicate well and collaborate effectively as part of a cross-functional team

Benefits

• Equity
• 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

Before you apply

• Refer to Job ID 23414 in your cover letter
• Only selected candidates will be contacted for an interview

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.