Senior QC Data Reviewer

AbCellera Biologics Inc.; Vancouver (WA); On-site; USD 62,000 - 77,000; Full time

Benefits offered by this job

Active Lifestyle Allowance

Equity

Annual bonus

RRSP contribution

Health benefits

Professional development

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

GMP knowledge

Analytical data review

Empower

LIMS

Education

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

Bachelor's degree + significant relevant experience

Tools

Empower

LIMS

Job description

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.