QA for QC Specialist (15-month contract)

AbCellera seeks a QA for QC Specialist for a 15-month contract role in Vancouver. The position involves reviewing and dispositioning quality control data from biologics clinical manufacturing, ensuring compliance with cGMP standards and regulatory requirements.

Responsibilities

• Review and disposition manual and electronic data from QC testing, environmental monitoring, and stability programs
• Approve protocols and reports for equipment qualification, validation, method transfers, and ongoing monitoring activities
• Document and escalate QC data issues including errors, inconsistencies, and out-of-specification results
• Participate in quality events such as deviations, CAPAs, and change controls to drive resolution
• Compile QC data for regulatory submissions and support responses to regulatory information requests

Requirements

• BSc in relevant scientific discipline with 5+ years industry experience, or MSc with 3+ years
• Strong background in analytical sciences, quality control, or biologic drug product manufacturing
• Thorough understanding of cGMP, Health Canada, FDA, EU, and ICH requirements
• High attention to detail with focus on data integrity and compliance
• Strong interpersonal skills and ability to work in cross-functional teams
• Ability to thrive in fast-paced environment with timely review and documentation

Compensation: CAD $82,000–$102,000 annually, plus annual performance bonus and 6% RRSP contribution