QA Specialist - Batch Record Review

AbCellera Biologics Inc.; Vancouver (WA); Sur place; USD 58 000 - 72 000; Plein temps

Avantages offerts par ce poste

Equity

Annual bonus

RRSP contribution

Health benefits

Lifestyle allowance

Résumé du poste

AbCellera is seeking a QA Specialist to join the Quality Assurance team and ensure clinical batches meet cGMP standards. You will review Batch Production Records and related docs for internal and CDMO operations, supporting IMP development from MCB/WCB to final DP.

This role emphasizes attention to detail, data integrity, and collaboration with Manufacturing, QC, MSAT, and external partners. You will help maintain inspection readiness and drive continuous improvement in manufacturing quality.

Qualifications

• BSc in a relevant scientific discipline with 5+ years of industry experience, or MSc with 3+ years, in Quality Assurance, Quality Control, or Manufacturing Operations within a cGMP-regulated biopharmaceutical or medical device environment.
• Experience reviewing manufacturing documentation for cell banking, drug substance, drug product, or medical devices/combination products, including on-the-floor review in a manufacturing environment.
• Thorough understanding of cGMPs and regulatory requirements from Health Canada, the FDA, the EU, and ICH.
• Apply strong critical thinking and organizational skills to manage multiple batch reviews at once and meet tight timelines.
• Exceptional attention to detail and a firm commitment to data integrity and compliance.
• Effective communication and cross-functional collaboration in a fast-paced environment.

Responsabilités

• Performing thorough compliance and accuracy reviews of executed batch records, logbooks, and electronic records for internal manufacturing operations, ensuring entries adhere to ALCOA++ principles, GDP and regulatory requirements.
• Providing Quality support on the floor and performing real-time batch review for internal manufacturing operations
• Supporting batch record reviews for external operations, including MCB/WCB, DS, DP, device assembly, combination products, and labeling and packaging operations
• Coordinating with Manufacturing, MSAT, QC, and external CDMO Quality units to resolve comments, request corrections, and track missing documentation, then compiling the completed Batch Record Review Checklists and final manufacturing record package for the authorized person's batch disposition
• Performing ERP materials release for internal manufacturing and testing operations in compliance with applicable SOPs and cGMP standards
• Conducting routine periodic reviews of electronic and paper-based equipment maintenance and calibration logs, providing Quality oversight of QC and Manufacturing operations
• Reviewing and participating in quality events such as deviations, investigations, product complaints, CAPAs, and change controls, driving investigation closeouts, and root cause determination
• Developing and reporting quality system metrics for review and release activities, and contributing to continuous improvement and risk assessments for manufacturing operations and batch disposition
• Maintaining facility inspection readiness, escalating risks to site leadership, and supporting inspections and audits of the clinical manufacturing facility

Connaissances

QA experience

cGMP knowledge

Document review

Regulatory compliance

Cross-functional collaboration

Formation

BSc in science

MSc in science

Outils

Quality management systems

Electronic records systems

Description du poste

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 who 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 enthusiastic QA Specialist to join our Quality Assurance team and help ensure our clinical batches meet the highest standards of cGMP compliance. In this role, you'll conduct comprehensive compliance reviews of executed Batch Production Records (BPRs) and related manufacturing documentation for batches made internally and through Contract Development and Manufacturing Organizations (CDMOs). You'll directly support investigational medicinal products (IMPs) at every stage of development, including Master/Working Cell Banks (MCB/WCB), Bulk Drug Substance (DS), Drug Product (DP), Finished Drug Product (FDP), devices, and combination products. If you're a detail-driven QA professional who wants your reviews to help get clinical programs to the patients who need them, we'd love to hear from you.

How you might spend your days

• Performing thorough compliance and accuracy reviews of executed batch records, logbooks, and electronic records for internal manufacturing operations, ensuring entries adhere to ALCOA++ principles, Good Documentation Practices (GDP), internal procedures, and regulatory requirements
• Providing Quality support on the floor and performing real-time batch review for internal manufacturing operations
• Supporting batch record reviews for external operations, including MCB/WCB, DS, DP, device assembly, combination products, and labelling and packaging operations
• Coordinating with Manufacturing, MSAT, QC, and external CDMO Quality units to resolve comments, request corrections, and track missing documentation, then compiling the completed Batch Record Review Checklists and final manufacturing record package for the authorized person's batch disposition
• Performing ERP materials release for internal manufacturing and testing operations in compliance with applicable SOPs and cGMP standards
• Conducting routine periodic reviews of electronic and paper-based equipment maintenance and calibration logs, providing Quality oversight of QC and Manufacturing operations
• Reviewing and participating in quality events such as deviations, investigations, product complaints, CAPAs, and change controls, driving investigation closeouts, and root cause determination
• Developing and reporting quality system metrics for review and release activities, and contributing to continuous improvement and risk assessments (evaluation, mitigation, documentation, and reporting) for manufacturing operations and batch disposition
• Maintaining facility inspection readiness, escalating risks to site leadership, and supporting inspections and audits of the clinical manufacturing facility, while staying current on applicable quality and regulatory requirements and trends

We’d love to hear from you if

• You have a BSc in a relevant scientific discipline with 5+ years of industry experience, or an MSc with 3+ years, in Quality Assurance, Quality Control, or Manufacturing Operations within a cGMP-regulated biopharmaceutical or medical device environment
• You have direct experience reviewing manufacturing documentation for cell banking, drug substance, drug product, or medical devices/combination products, including on-the-floor review in a manufacturing environment
• You have a thorough understanding of cGMPs and regulatory requirements from Health Canada, the FDA, the EU, and ICH
• You apply strong critical thinking and organizational skills to manage multiple batch reviews at once and meet tight timelines
• You bring exceptional attention to detail and a firm commitment to data integrity and compliance
• You communicate well and collaborate effectively as part of a cross-functional team in a fast-paced environment

What we offer

AbCellera’s hiring range for this role is CAD $82,000 - $102,000 annually, commensurate with your education and job-related knowledge, skills, and experience. In addition to base salary, we offer equity, annual bonus dependent on individual 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.