Specialist, QA for Qc

3 months ago

Vancouver, Canada AbCellera Biologics Full time

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 a (Senior) Specialist, QA for QC to oversee the review and disposition of all data generated from the cGMP Quality Control (QC) labs supporting AbCellera’s state-of-the-art biologics drug substance clinical manufacturing facility. As the responsible QA Specialist overseeing all QC laboratory activities, you will play an important role in ensuring that our processes and procedures meet the highest standards of quality and compliance.

**How you might spend your days**
- Developing and supporting the development of all departmental processes, documents/procedures and records needed for QA of QC related operations
- Reviewing and disposition of all manual and electronic data associated with the testing of incoming materials/components, environmental/clean utilities, in-process testing of bulk DS/DP, FDP testing, stability programs, retention/reference samples, reference standards/materials, and cell banking activities
- Reviewing and approval of protocols and reports related to QC equipment and/or instrumentation qualification and validation, QC method transfers, and QC method verification/qualification/validation
- Reviewing and approval of ongoing monitoring reports, such as EM and utility trending, APQRs, QC method monitoring, etc
- Documenting and escalating issues related to QC data, including errors, inconsistencies, non-compliance, and data suspected or confirmed to be out of trend (OOT) or out of specification (OOS). Review and disposition of QC data conducted during investigations and product complaint investigations
- Supporting the compilation and review of QC generated data to be used for regulatory submissions (e.g. IND/CTA) and partnering activities. Support the generation of responses to official requests for additional information
- Maintaining a strong working knowledge of relevant compendia, regulatory standards, and guidance and QC instrumentation and operations

**We’d love to hear from you if**
- You have a Bachelor’s or Master’s Degree in an applicable science and 6+ years of relevant QC and QA experience
- You have strong knowledge of QC and QA operations, QC instrumentation, electronic systems and data formats
- You have strong knowledge and understanding of data integrity requirements and knowledge of manufacturing and testing requirements of biological products
- You have working or educational knowledge of cGMP, USP, ICH, EP and FDA guidelines
- You are someone who is enthusiastic about adopting innovative approaches that enable agile, sustainable compliance.
- You have experience leading, overseeing, participating, and executing QA for QC activities
- You are comfortable and work well within cross-functional teams providing oversight and support in an evolving, complex, and dynamic environment

**What we offer**

AbCellera’s hiring range for this role is CAD $72,600 - $99,800 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, opportunity for flexible work arrangements, 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

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