QA Specialist, cGMP Batch Review

AbCellera Biologics Inc.; Vancouver (WA); Presencial; USD 58 000 - 72 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Equity

Annual bonus

RRSP contribution

Health benefits

Lifestyle allowance

Resumo da oferta

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.

Qualificações

• 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.

Responsabilidades

• 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

Conhecimentos

QA experience

cGMP knowledge

Document review

Regulatory compliance

Cross-functional collaboration

Formação académica

BSc in science

MSc in science

Ferramentas

Quality management systems

Electronic records systems

Descrição da oferta de emprego

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.