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Added 2 mins ago
VP
Intelligent P&ID Systems Specialist
Vista Projects Limited
Calgary, AB
- Full-time
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Added 2 mins ago
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- Full-time
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AbCellera

QA Specialist - Batch Record Review

Vancouver, BC, Canada

$82,000 to $102,000 CAD / year

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Job details

Pay: $82,000 to $102,000 CAD / year
Posting language: English
Posted: Oct 8, 2026

Original 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 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.

To apply

Please submit your application through our website and refer to Job ID 23414 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.

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More about this job

Responsibilities

The QA Specialist will conduct comprehensive compliance reviews of executed batch production records and manufacturing documentation to ensure adherence to cGMP standards. They will also provide quality support on the floor, manage quality events like deviations and CAPAs, and coordinate with cross-functional teams to ensure inspection readiness.

Requirements

Candidates must hold a BSc with 5+ years or an MSc with 3+ years of experience in a cGMP-regulated biopharmaceutical or medical device environment. A thorough understanding of regulatory requirements from Health Canada, the FDA, the EU, and ICH is required.

Skills

Batch record review
cGMP compliance
Quality assurance
Manufacturing operations
ALCOA++ principles
Good documentation practices
Regulatory compliance
Deviation management
CAPA
Change control
Root cause analysis
Quality metrics
Risk assessment
Inspection readiness
Critical thinking
Data integrity

Benefits

Equity
Annual bonus
6% RRSP contribution
Active lifestyle allowance
Annual vacation
Professional development opportunities
Comprehensive health benefits
Scientific and technical mentorship

Visa sponsorship

Not detected in the job text

Keywords

QA Specialist
Batch Record Review
cGMP
Biopharmaceutical
Medical Device
Quality Assurance
Quality Control
Manufacturing Operations
ALCOA++
GDP
CDMO
IMP
Cell Banking
Drug Substance
Drug Product
Combination Products
ERP
SOP
Deviation
CAPA
Change Control
Root Cause Determination
Quality System Metrics
Risk Assessment
Inspection Readiness
Health Canada
FDA
EU
ICH
Data Integrity

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