Clinical QA Operations Specialist (15-Month Contract)

AbCellera Biologics Inc.; Vancouver (WA); Hybrid; USD 58,000 - 72,000; Full time

Benefits offered by this job

Annual bonus

RRSP contribution 6%

Active Lifestyle Allowance CAD 1500

Health benefits

Professional development

Mentorship

Job summary

AbCellera Biologics Inc. is seeking an enthusiastic QA Operations Specialist for a 15-month contract to ensure clinical batches meet cGMP standards.

You will author, review, and maintain documentation behind drug manufacturing activities, ensuring records are accurate, complete, and inspection-ready. Ideal candidates hold a BSc with 5+ years or MSc with 3+ years in analytical sciences or manufacturing, with strong data integrity and cross-functional collaboration skills.

Qualifications

• BSc with 5+ years or MSc with 3+ years in analytical sciences, quality control, or biologics manufacturing.
• Strong understanding of cGMPs and regulatory requirements (Health Canada, FDA, EU, ICH).
• Attention to detail and commitment to data integrity and compliance.

Responsibilities

• Provide QA support for GMP QC and Drug Substance manufacturing operations, including on-the-floor support and real-time batch review.
• Review GMP documents and raw data for compliance and data integrity to support disposition of clinical batches.
• Support review of batch records from external operations (DS, DP, FDP assembly, labeling and packaging).
• Perform ERP materials release for internal manufacturing and testing operations to support on-time manufacturing.
• Develop, implement, and revise quality procedures and documentation to maintain compliance and oversight of QC and Manufacturing.
• Review and participate in quality events such as deviations, investigations, CAPAs, and change controls; drive closeouts and root cause analysis.
• Participate in risk assessments for manufacturing operations and document findings.
• Maintain inspection readiness and support inspections and audits of the clinical manufacturing facility.
• Stay current on applicable quality/regulatory requirements and evolving trends.

Skills

Quality assurance

cGMP knowledge

Data integrity

Analytical sciences

Cross-functional collaboration

Education

BSc with 5+ years

MSc with 3+ years

Job description

AbCellera Biologics Inc. is seeking an enthusiastic QA Operations Specialist for a 15-month contract to ensure clinical batches meet cGMP standards.

You will author, review, and maintain documentation behind drug manufacturing activities, ensuring records are accurate, complete, and inspection-ready. Ideal candidates hold a BSc with 5+ years or MSc with 3+ years in analytical sciences or manufacturing, with strong data integrity and cross-functional collaboration skills.