QA Specialist

From target to the clinic. AbCellera’s platform integrates biology, computation, and engineering to develop impactful antibody-based medicines. We’re scientists, engineers, and business professionals who work together to turn scientific insights into breakthrough medicines. We pursue truth and scientific rigor. We think independently, act with conviction, and have the courage to work at the edge of the unknown. We offer the opportunity to stretch and explore, and to work on things that matter.

We are looking for an enthusiastic QA Specialist to join our Quality Assurance Operations team. You will be responsible for ensuring that manufactured and tested clinical batches are in compliance with current Good Manufacturing Practices (cGMP). You will be involved in authoring, reviewing and maintaining documentation related to drug manufacturing and testing as per Good Documentation Practices (GDP). 

How you might spend your days

• Providing quality oversight and support for GMP Quality Control and manufacturing operations of Drug Substance (DS) 
• Supporting the development and implementation of quality procedures and systems ensuring compliance and oversight of Quality Control and Manufacturing Operations 
• Reviewing and supporting the implementation/revision of testing manufacturing procedures/documentation
• Reviewing GMP documents and raw data, including executed analytical and batch records in paper and/or electronic forms, for compliance with applicable procedures and standards (including data integrity) to support the disposition of clinical batches
• Reviewing and participating in quality events such as deviations, investigations (including product complaints), CAPAs, and change controls to drive investigation closeouts and determine root cause
• Participating in risk assessments related to manufacturing operations including risk evaluation, mitigation, documentation and reporting  
• Maintaining current knowledge of applicable quality and regulatory requirements and evolving trends
• Maintaining facility inspection readiness, including identification and escalation of risks to members of the site leadership team. Supporting inspections and audits of the clinical manufacturing facility

We’d love to hear from you if

• You have a strong background in analytical sciences, quality control or manufacturing of biologically derived drug products 
• You have a BSc in a relevant scientific discipline with a minimum of 5 years of industry experience or an MSc and 3+ years of industry experience
• You have experience in a fast paced environment, ensuring timely review of QC tests,  procedures, batch documentation, logbooks, deviations, CAPAs and change controls
• You have high attention to detail with a focus on data integrity and compliance
• You have strong interpersonal skills with the ability to work collaboratively as a member of a cross-functional team
• You have a passion for science, operational excellence, and innovation
• You have a thorough understanding of cGMPs, Health Canada, FDA EU and ICH requirements

What we offer

AbCellera’s hiring range for this role is CAD $76,200 - $95,300 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 we prioritize teams and social groups to build community and connections across AbCellera.

About AbCellera

AbCellera is a global company focused on delivering breakthrough medicines that alleviate suffering, extend lives, and improve health. Our platform includes fully integrated capabilities to create first-in-class and best-in-class antibody medicines, from discovery to clinical manufacturing. 

We are using our technological advantage to develop programs across multiple indications including endocrine and metabolic conditions, oncology, and inflammation and autoimmunity. We’re advancing programs involving complex transmembrane proteins, bispecifics, and antibody drug conjugates. 

Creating medicines is the most important work we can do. 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 23274 in your cover letter. We apologize in advance, but we receive a large volume of applications and are only able to contact those who are selected for an interview.

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