Senior QC Data Reviewer - GMP Data Integrity Expert

Peptide Atlas; Vancouver; Vor Ort; CAD 88.000 - 110.000; Vollzeit

Benefits dieser Stelle

Equity

Annual bonus

RRSP contribution

Health benefits

Professional development

Zusammenfassung

AbCellera is seeking an experienced QC Data Reviewer to support internal and external GMP testing across clinical development programs. You will independently review analytical and microbiological data for release, stability, and transfer activities, ensuring accuracy, traceability, and GMP compliance.

You will work with analysts to resolve documentation gaps, support deviations investigations, and contribute to regulatory submissions.

Qualifikationen

• Master's degree in a scientific field with 5+ years GMP QC experience.
• Hands-on GMP lab experience including independent QC data review.
• Experience reviewing release, stability, method validation/transfer data.

Aufgaben

• Perform independent GMP review of analytical and microbiological data.
• Verify calculations, sample IDs, acceptance criteria and reported results.
• Ensure ALCOA+ data integrity and audit trails in electronic records.
• Support method transfer and validation activities and final study packages.
• Collaborate with analysts to resolve data gaps and deviations.
• Support regulatory submissions with QC content and SOP updates.

Kenntnisse

GMP data review

ALCOA+ data integrity

Data analysis

Empower & LIMS literacy

HPLC/UPLC, GC, UV/Vis

Method validation/verification

Deviations investigations

Ausbildung

Master's degree in Chemistry, Biochemistry, Microbiology, Pharmaceutical Sciences, Life Sciences

Bachelor's degree with significant relevant experience

Tools

Empower

LIMS

Jobbeschreibung

AbCellera is seeking an experienced QC Data Reviewer to support internal and external GMP testing across clinical development programs. You will independently review analytical and microbiological data for release, stability, and transfer activities, ensuring accuracy, traceability, and GMP compliance.

You will work with analysts to resolve documentation gaps, support deviations investigations, and contribute to regulatory submissions.