Senior QC Data Reviewer: Drive Data Integrity & Impact

AbCellera Biologics Inc.; Vancouver (WA); Presencial; USD 62 000 - 77 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Active Lifestyle Allowance

Equity

Annual bonus

RRSP contribution

Health benefits

Professional development

Resumo da oferta

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

You will independently review analytical and microbiological data for release, stability, raw material, validation, and transfer activities, ensuring accuracy, traceability, and compliance with GMP requirements. You will review data, calculations, chromatograms, and instrument outputs, escalate OOS/OOT events, and maintain ALCOA+ data integrity.

Qualificações

• Master's degree in Chemistry, Biochemistry, Microbiology, Pharmaceutical Sciences, Life Sciences or related field.
• 5+ years of GMP experience in pharmaceutical/biotech QC (Bachelor's with substantial experience acceptable).
• Hands-on GMP lab experience with independent QC data review and analytical data review.
• Knowledge of GMP, ALCOA+ data integrity, OOS/OOT, deviations, investigations, CAPA, and change control.

Responsabilidades

• Perform independent GMP review of analytical and microbiological data across release, stability, and related testing.
• Review raw data, calculations, chromatograms, spectra, instrument outputs and records for accuracy and compliance.
• Verify calculations, sample IDs, acceptance criteria, and reported results; escalate issues.
• Ensure data integrity and review of electronic records and audit trails (ALCOA+).
• Support regulatory submissions with analytical content and contribute to QC SOPs and work instructions.
• Provide technical review and scientific judgment for deviations, investigations, CAPAs and transfers.

Conhecimentos

GMP knowledge

Analytical data review

Empower

LIMS

Formação académica

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

Bachelor's degree + significant relevant experience

Ferramentas

Empower

LIMS

Descrição da oferta de emprego

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

You will independently review analytical and microbiological data for release, stability, raw material, validation, and transfer activities, ensuring accuracy, traceability, and compliance with GMP requirements. You will review data, calculations, chromatograms, and instrument outputs, escalate OOS/OOT events, and maintain ALCOA+ data integrity.