QA for QC Specialist: Data Integrity & Compliance

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

Benefits offered by this job

Annual bonus

RRSP contribution

Health benefits

Lifestyle allowance

Job summary

AbCellera Biologics Inc. is seeking a QA for QC Specialist to join our Quality Assurance Operations team. You will review data from QC laboratories and ensure data integrity, disposition investigations, and regulatory readiness for IND/CTA submissions.

The role requires a BSc with 5+ years or MSc with 3+ years in analytical sciences or biologics manufacturing, and a strong grasp of cGMPs and regulatory requirements. A competitive CAD salary and bonus are offered in a dynamic biotech setting.

Qualifications

• Strong background in analytical sciences and quality control for biologics.
• Experience manufacturing biologically derived drug products.
• Familiarity with cGMPs and regulatory standards.

Responsibilities

• Develop and support QA of QC-related operations documentation.
• Review data from QC labs including materials, environmental monitoring, and stability programs.
• Approve protocols and reports for equipment qualification and method validation.
• Document QC data issues and participate in CAPAs and change controls.
• Support regulatory submissions and site inspections readiness.

Skills

Analytical sciences

Quality control

Biologics manufacturing

Education

BSc in scientific discipline

MSc in relevant field

Job description

AbCellera Biologics Inc. is seeking a QA for QC Specialist to join our Quality Assurance Operations team. You will review data from QC laboratories and ensure data integrity, disposition investigations, and regulatory readiness for IND/CTA submissions.

The role requires a BSc with 5+ years or MSc with 3+ years in analytical sciences or biologics manufacturing, and a strong grasp of cGMPs and regulatory requirements. A competitive CAD salary and bonus are offered in a dynamic biotech setting.