Senior QC Data Reviewer

The role

You will provide independent GMP review of analytical and microbiological data for clinical development programs. This includes reviewing raw data, calculations, and laboratory records to ensure compliance with GMP requirements and data integrity.

What you will do

• Perform independent GMP review of analytical and microbiological data from internal and external partners
• Review raw data, calculations, chromatograms, spectra, and laboratory records for compliance
• Verify calculations, sample identification, acceptance criteria, and reported results
• Escalate OOS, OOT, atypical results, trends, and deviations
• Ensure laboratory data meets ALCOA+ data integrity expectations
• Review data for method development, qualification, validation, and transfer activities
• Partner with analysts and scientists to resolve documentation gaps
• Provide technical review for deviations, investigations, and CAPAs
• Review Certificates of Analysis and stability reports
• Support preparation of analytical and microbiological content for regulatory submissions

Required qualifications

• Master's degree in Chemistry, Biochemistry, Microbiology, Pharmaceutical Sciences, Life Sciences, or a related scientific field, with 5+ years of relevant GMP experience in pharmaceutical or biotechno
• A Bachelor's degree with significant additional relevant experience will also be considered
• Hands-on experience in a GMP laboratory, including independent QC data review
• Ability to review analytical data from techniques such as UPLC, UV/Vis, ELISA, CE-SDS, iCIEF, spectroscopy, and wet chemistry
• Experience reviewing release, stability, method validation/qualification/verification, and method transfer data
• Strong knowledge of GMP, ALCOA+ data integrity principles, OOS/OOT, deviations, investigations, CAPA, and change control
• Comfortable working with laboratory systems such as Empower and LIMS

Nice to have

• microbiology data review is an asset
• previous QA or independent GMP data-review experience (highly valued)

Benefits

• equity
• annual bonus dependent on team and company performance
• 6% (non-match) RRSP contribution
• CAD $1,500 annual Active Lifestyle Allowance
• annual vacation
• professional development opportunities
• comprehensive health benefits
• Scientific and technical mentorship

Before you apply

• Please submit your application through our website and refer to Job ID 23409 in your cover letter
• Only those selected for an interview will be contacted

About the company

AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology, women’s health, immunology, and oncology.