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AbCellera Verified
Biotechnology, Pharmaceutical, Artificial Intelligence, Drug Discovery

Senior QC Data Reviewer

Vancouver, BCOnsiteFull TimeSeniorCA$88,000–CA$110,000 /yrPosted 1 month ago

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Required skills

  • GMP
  • data integrity
  • ALCOA+
  • HPLC/UPLC
  • GC
  • UV/Vis
  • spectroscopy
  • wet chemistry
  • method validation
  • method qualification

Nice to have

  • QA
  • independent GMP data-review
  • ELISA
  • CE-SDS
  • iCIEF
  • bioburden

Role summary

We are seeking an experienced Senior QC Data Reviewer to provide independent review of analytical and microbiological data for GMP testing across clinical development programs. This role ensures accuracy, traceability, and compliance with methods, specifications, protocols, SOPs, and GMP requirements, with a strong focus on data integrity. You will review data from various techniques (HPLC/UPLC, GC, UV/Vis, spectroscopy, wet chemistry, bioburden, endotoxin, environmental monitoring) and laboratory records, verify results, escalate irregularities, and ensure ALCOA+ data integrity. You will also review data for method validation/qualification/transfer, support investigations, and contribute to regulatory submissions and process improvements. A Master's degree in a relevant scientific field with 5+ years of GMP experience in QC is required, along with hands-on experience in GMP laboratory data review and knowledge of GMP, ALCOA+, OOS/OOT, and deviations. Experience with Empower and LIMS is preferred.

Each of us cares about someone who will need medicines. That’s why our vision is to repeatedly beat the odds to deliver breakthrough medicines to patients that need them. We pursue truth and scientific rigour and have the courage to work at the edge of the unknown.

We're looking for an experienced QC Data Reviewer to support internal and external GMP testing across our clinical development programs. In this role, you'll provide independent review of analytical and microbiological data generated for release, stability, raw material, validation, qualification, and method transfer activities. You'll make sure every result is accurate, traceable, and compliant with approved methods, specifications, protocols, SOPs, and GMP requirements, with data integrity at the centre of your work. With a significant volume of QC activity ahead across multiple projects, your reviews will keep data moving and support timely product disposition. If you're a detail-driven QC professional who wants your work to directly help get clinical programs to the patients who need them, we'd love to hear from you.

How you might spend your days

  • Performing independent GMP review of analytical and microbiological data from internal QC laboratories and external testing partners, covering release, stability, raw material, in-process, drug substance, drug product, and placebo testing across techniques such as HPLC/UPLC, GC, UV/Vis, spectroscopy, wet chemistry, bioburden, endotoxin, environmental monitoring, and utilities testing
  • Reviewing raw data, calculations, chromatograms, spectra, instrument outputs, worksheets, and laboratory records for accuracy, completeness, traceability, and compliance with approved methods, specifications, protocols, SOPs, and GMP requirements
  • Verifying calculations, sample identification, acceptance criteria, and reported results, and escalating OOS, OOT, atypical results, trends, deviations, and other data irregularities
  • Ensuring laboratory data and records meet ALCOA+ data integrity expectations, including review of electronic records and audit trails
  • Reviewing data and reports for method development, qualification, validation, verification, and transfer activities, along with instrument and equipment qualification, calibration, and preventive maintenance records, and supporting completion of final study packages
  • Partnering with analysts and scientists to resolve documentation gaps, corrections, and incomplete testing in a timely and compliant manner
  • Providing technical review and scientific judgment in support of deviations, investigations, OOS/OOT assessments, root cause analysis, and CAPAs
  • Reviewing Certificates of Analysis, stability reports, and other controlled QC reports to support timely data release in line with program and manufacturing timelines
  • Supporting the preparation of analytical and microbiological content for regulatory submissions, providing QC support to program and CMC sub-teams, and contributing to the development and revision of QC SOPs, forms, templates, and work instructions
  • Driving continuous improvement in QC processes, data integrity, and reviewer practices by identifying recurring issues, coaching analysts and scientists on good documentation practices, and contributing to inspection and audit readiness

    • We’d love to hear from you if

  • You have a 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 biotechnology QC (a Bachelor's degree with significant additional relevant experience will also be considered)
  • You have hands-on experience in a GMP laboratory, including independent QC data review, with a strong ability to review analytical data from techniques such as UPLC, UV/Vis, ELISA, CE-SDS, iCIEF, spectroscopy, and wet chemistry (microbiology data review is an asset)
  • You have experience reviewing release, stability, method validation/qualification/verification, and method transfer data
  • You have strong knowledge of GMP, ALCOA+ data integrity principles, OOS/OOT, deviations, investigations, CAPA, and change control
  • You are comfortable working with laboratory systems such as Empower and LIMS
  • You critically evaluate analytical data to identify discrepancies, trends, documentation gaps, and issues that need escalation
  • You are detail-oriented and organized, managing multiple priorities against release, stability, manufacturing, and regulatory timelines
  • You communicate clearly, collaborate well across functions, and bring sound scientific judgment, accountability, and professionalism
  • You are proactive and solutions-focused, and comfortable making independent decisions in a fast-paced GMP environment
  • You have previous QA or independent GMP data-review experience (highly valued)

    • What we offer

    AbCellera’s hiring range for this role is CAD $88,000 - $110,000 annually, commensurate with your education and job-related knowledge, skills, and experience. In addition to base salary, we offer equity, annual bonus dependent on team and company performance, and a 6% (non-match) RRSP contribution.

    You will have a CAD $1,500 annual Active Lifestyle Allowance, annual vacation, professional development opportunities, and comprehensive health benefits. Scientific and technical mentorship is a priority. And you’ll find a strong sense of community and connections across AbCellera through our work, clubs, and socials.

    About AbCellera

    Creating medicines is the most important work we can do.

    We are a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology, women’s health, immunology, and oncology. We have built a platform for advancing antibody drug programs from target to clinic, and we are using it to build our internal pipeline. Today, our pipeline includes two drug candidates in clinical development, two preclinical development candidates (DCs) in Investigational New Drug (IND)-enabling activities, and more than 20 active discovery programs across multiple modalities and indications.

    We believe that when tenacious people share a vision and work together, they can truly have a positive impact. That’s why we hire for character and intelligence, not just for CVs or experience.

    We look for people with drive and energy. People we trust. People who need to know their days are being well spent. That their work really matters. In the end, our success will be measured by the impact of our medicines.

    To apply

    Please submit your application through our website and refer to Job ID 23409 in your cover letter. We receive a large volume of applications and are only able to contact those who are selected for an interview. All communication from our Talent Discovery team will come from an @abcellera.com email address.

    Ready to apply?
    You'll be redirected to AbCellera's application page.

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