QA Specialist

AbCellera is breaking the barriers of conventional drug development to propel antibody-based medicines from target to clinic. We are a team of scientists, engineers, creatives, and business professionals who believe that advancing science enhances lives. We have developed technologies to unlock high-value drug targets, including antibody-drug conjugates and T-cell engagers for cancer, and complex transmembrane proteins for indications such as metabolic and endocrine conditions, pain, and autoimmunity.

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 that discovers and develops antibody-based medicines that help people live longer, happier, and more productive lives. We are focused on bringing innovative medicines to patients, both by advancing our internal pipeline of programs and partnering with companies that have novel science or innovative technology.

And it all starts with our team. We’ve built a place where people feel they are part of something bigger than themselves. A place that exists to push the limits of science and technology, and aims to bring better therapies to patients.

We look for people with drive and energy. Idealists. People we love and people we trust. This may be unconventional, but it is the key to our success. 

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.