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Added 6 mins ago
F
Technical Consultant (Data & AI)
Fastloop
Vancouver, BC
- Full-time
…generalist who can bridge the gap between a raw data lake and a functional, agentic AI…
Added 7 mins ago
HT
Designer, Development (Service)
Husky Technologies
Bolton, ON
- Full-time
Identify possible root causes and verify them through internal and external testing
Added 7 mins ago
HT
Product Development Engineer
Husky Technologies
Bolton, ON
- Full-time
Create system level concept designs in various levels of detail including function block diagrams, CAD layouts, functional decomposition.
Added 7 mins ago
TQ
FSQA Specialist
Top Quality Recruitment (TQR)
Vaughan, ON
- Full-time
…working closely with Production, Sanitation, and other cross-functional…
Added 7 mins ago
SJ
Sr GRC Analyst
So Jobs
Mississauga, ON
- $99,100 to $132,100 CAD / year
- Full-time
Support testing, documentation, remediation tracking, and compliance reporting activities.
Added 7 mins ago
HT
Designer, Development (Mechanical)
Husky Technologies
Bolton, ON
- Full-time
Create system level concept designs in various levels of detail including function block diagrams, CAD layouts, functional decomposition.
Added 7 mins ago
DI
QA Analyst (Bilingual - Mandarin/ English)
Dawn InfoTek
Toronto, ON
- Contract
Execute thorough regression testing to verify that the UI conversion introduces no functional changes or defects to the existing applications.
Added 7 mins ago
HT
Industrial Software Validation
Husky Technologies
Bolton, ON
- Full-time
Proven ability to lead validation planning and testing within cross-functional teams
Added 7 mins ago
W
Senior Process Automation & Controls Engineer
Worley
Calgary, AB
- Full-time
Support commissioning, startup, testing, and troubleshooting activities.
Added 7 mins ago
W
Senior Process Automation & Controls Engineer
Worley
AB · Edmonton, AB
- Full-time
Support commissioning, startup, testing, and troubleshooting activities.
Added 7 mins ago
LS
Quality Assurance Engineer
LeverageTek Staffing Solutions
Canada
- Temporary
Verify functional and non-functional requirements for cloud-native microservices.
Added 7 mins ago
FC
analyste programmeur dotnet
FOP Consultants
Quebec, QC
- Full-time
Perform unit, functional, integration, performance, and load testing.
Added 7 mins ago
HT
Applications Engineer
Husky Technologies
Bolton, ON
- Full-time
Collaborate with cross-functional experts across Product Development, Advanced Development, Testing, and Validation teams to translate emerging technologies into scalable, customer-focused…
Added 7 mins ago
HT
Advanced Applications Blow Molding Specialist
Husky Technologies
Bolton, ON
- Full-time
Work closely with a team of cross-functional domain experts in Advantage+Elite, Product Development and Validation teams to integrate innovations and new technologies into practical…
Added 9 mins ago
S
Illumination Engineer
SYSTRA
Toronto, ON
- Full-time
…design, LED driver integration, optical simulation, and cross-functional collaboration within a product development environment. Familiarity with smart lighting technologies (NLC) and a…
Added 9 mins ago
Software Developer
ATS Automation
ON · Woodbridge, ON
…EV products including battery cell, module and pack leak and functional testing but also serve other industries including the Life Sciences group, Aerospace Industry, traditional…
Added 9 mins ago
Junior Software Developer
ATS Automation
ON · Woodbridge, ON
…EV products including battery cell, module and pack leak and functional testing but also serve other industries including the Life Sciences group, Aerospace Industry, traditional…
Added 9 mins ago
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Manufacturing Engineer
AGI | Global Food Infrastructure
Swift Current No. 137, SK · Swift Current, SK
- Full-time
As a highly cross-functional role, you will work closely with the Purchasing, Production, and Sales teams, developing both your technical expertise and professional skills while…
Added 9 mins ago
Senior Data Engineer
BitGo
Toronto, ON
Experience with unit and functional testing and debugging
Added 9 mins ago
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UAT Manager
BMO
Toronto, ON · YNG
- Full-time
Performs required business testing on technical solutions to ensure that new product, process, learning program or other technical changes introduced to customers and/or employees meet…
Added 9 mins ago
Senior Internal Auditor
Twilio
BC
Also, while we are a remote-first company, you may be asked to report in person on an ad-hoc basis for team gatherings, functional off-sites or customer meetings.
Added 21 mins ago
XI
Senior Designer, UX and Customer Journey
Xplore Inc.
Woodstock, NB
- Full-time
…defining how success will be measured. You will guide cross-functional teams to translate customer needs and CX strategy into intuitive, seamless and personalized experiences via app, web,…
Added 21 mins ago
XI
Senior Designer, UX and Customer Journey
Xplore Inc.
Calgary, AB
- Full-time
…defining how success will be measured. You will guide cross-functional teams to translate customer needs and CX strategy into intuitive, seamless and personalized experiences via app, web,…
Added 21 mins ago
XI
Senior Designer, UX and Customer Journey
Xplore Inc.
Fredericton, NB
- Full-time
…defining how success will be measured. You will guide cross-functional teams to translate customer needs and CX strategy into intuitive, seamless and personalized experiences via app, web,…
Added 22 mins ago
KS
Supply Chain Business Analyst
Kelly Services (Canada), Ltd.
Toronto, ON
- $40 to $50 CAD / hour
- Contract
Participate in cross-functional workshops to improve operational efficiency, service levels, and customer experience

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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