QA for QC Specialist (15-month contract)

The role

This person will review and disposition data generated from cGMP Quality Control labs. They will oversee laboratory activities to ensure processes and procedures meet quality and compliance standards for biologics clinical manufacturing.

What you will do

• Developing and supporting departmental processes, procedures, documents, and records for QA of QC-related operations
• Reviewing manual and electronic data from testing of incoming materials, environmental monitoring, clean utilities, in-process bulk DS/DP, FDP, stability programs, retention/reference samples, referen
• Approving protocols and reports for QC equipment and instrument qualification and validation, method transfers, and method verification/qualification/validation
• Monitoring reports such as EM and utility trending, APQRs, and QC method monitoring
• Documenting and escalating QC data issues including errors, inconsistencies, non-compliance, and suspected or confirmed OOT/OOS results
• Dispositioning QC data generated during investigations and product complaint investigations
• Participating in quality events such as deviations, CAPAs, and change controls
• Compiling and reviewing QC data for regulatory submissions and partnering activities
• Supporting responses to official requests for additional information
• 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
• Strong background in analytical sciences, quality control, or manufacturing of biologically derived drug products
• Ability to ensure timely review of QC testing, procedures, batch documentation, logbooks, deviations, CAPAs, and change controls
• High attention to detail with a focus on data integrity and compliance
• Strong interpersonal skills
• Ability to work collaboratively as a member of a cross-functional team
• Thorough understanding of cGMPs, Health Canada, FDA EU, and ICH requirements

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.