Senior QC Data Reviewer: GMP Analytics & Data Integrity

AbCellera Biologics Inc.; Vancouver; On-site; CAD 88,000 - 110,000; Full time

Benefits offered by this job

Equity

Annual bonus

RRSP contribution

Active lifestyle allowance

Health benefits

Professional development

Job summary

AbCellera Biologics Inc. is seeking an experienced QC Data Reviewer to support internal and external GMP testing across clinical programs.

You will provide independent review of analytical and microbiological data generated for release, stability, and transfer activities, ensuring accuracy, traceability, and GMP compliance. The role involves reviewing data from techniques such as HPLC/UPLC, UV/Vis, and microbiology, maintaining data integrity and supporting regulatory submissions.

Qualifications

• Master’s degree in Chemistry, Biochemistry, Microbiology, Pharmaceutical Sciences, Life Sciences, or related field.
• 5+ years of GMP experience in pharmaceutical/biotechnology QC (Bachelor with significant experience considered).
• Hands-on GMP laboratory experience with independent QC data review.
• Experience reviewing release, stability, method validation/qualification/verification, and method transfer data.
• Knowledge of GMP, ALCOA+ data integrity, OOS/OOT, deviations, investigations, CAPA, and change control.
• Comfort working with Empower and LIMS.

Responsibilities

• Perform independent GMP review of analytical and microbiological data across release, stability, raw material, in-process testing.
• Review raw data, calculations, chromatograms, spectra, instrument outputs, and laboratory records for accuracy and traceability.
• Verify calculations, sample IDs, acceptance criteria, and reported results; escalate OOS/OOT and deviations.
• Ensure ALCOA+ data integrity for electronic records and audit trails.
• Support method development, qualification, validation, verification, and transfer activities; maintain qualification records.
• Collaborate with analysts to address documentation gaps and corrective actions.
• Provide technical review and scientific judgment for deviations, investigations, CAPAs.
• Review Certificates of Analysis and stability reports to support timely data release.
• Contribute to regulatory submissions content and QC SOPs.
• Drive continuous QC process improvements and audit readiness.

Skills

GMP data review

ALCOA+ data integrity

Analytical data interpretation

Cross-functional collaboration

Attention to detail

Education

Master’s degree in Chemistry, Biochemistry, Microbiology, Pharmaceutical Sciences, Life Sciences, or related field

Bachelor’s degree with significant GMP experience

Tools

Empower

LIMS

Job description

AbCellera Biologics Inc. is seeking an experienced QC Data Reviewer to support internal and external GMP testing across clinical programs.

You will provide independent review of analytical and microbiological data generated for release, stability, and transfer activities, ensuring accuracy, traceability, and GMP compliance. The role involves reviewing data from techniques such as HPLC/UPLC, UV/Vis, and microbiology, maintaining data integrity and supporting regulatory submissions.