The posting
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 are looking for an enthusiastic QA for QC Specialist to join our Quality Assurance Operations team and help ensure the quality and compliance of the data behind our biologics clinical manufacturing. In this role, you'll review and disposition the data generated from the cGMP Quality Control (QC) labs, which support our state-of-the-art biologics drug substance clinical manufacturing facility. As the QA partner for QC, you’ll oversee laboratory activities and help make sure our processes and procedures meet the highest standards of quality and compliance. If you’re a detail-driven QA professional who wants to play a hands-on role in bringing clinical-stage therapies to patients, we’d love to hear from you
How you might spend your days
- Developing and supporting departmental processes, procedures, documents, and records for QA of QC-related operations
- Reviewing manual and electronic data from the testing of incoming materials and components, environmental monitoring and clean utilities, in-process bulk DS/DP, FDP, stability programs, retention/reference samples, reference standards, and cell banking activities
- Approving protocols and reports for QC equipment and instrument qualification and validation, method transfers, and method verification/qualification/validation, along with ongoing monitoring reports such as EM and utility trending, APQRs, and QC method monitoring
- Documenting and escalating QC data issues, including errors, inconsistencies, non-compliance, and suspected or confirmed OOT/OOS results, and dispositioning QC data generated during investigations and product complaint investigations
- Participating in quality events such as deviations, CAPAs, and change controls to drive closeouts and root cause determination
- Compiling and reviewing QC data for regulatory submissions (e.g., IND/CTA) and partnering activities, and supporting responses to official requests for additional information
- Maintaining facility inspection readiness, escalating risks to site leadership, and supporting inspections and audits of the clinical manufacturing facility, while keeping a strong working knowledge of relevant compendia, regulatory standards, guidance, and QC instrumentation and operations
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) and a strong background in analytical sciences, quality control, or manufacturing of biologically derived drug products
- You thrive in a fast-paced environment, ensuring timely review of QC testing, 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 thorough understanding of cGMPs, Health Canada, FDA EU, and ICH requirements
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 an 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 are 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 23415 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.
