QA Associate, Document Management Coordinator
AbCellera is an energetic, and rapidly growing tech company with an amazing team that searches, decodes, and analyzes natural immune systems to find antibodies that its partners can develop into drugs to prevent and treat disease. Working at the interface of computation, engineering, and biology, AbCellera is rebuilding the front-end process of how drugs are discovered with a discovery platform that integrates modern technologies from engineering, microfluidics, single-cell analysis, high-throughput genomics, machine learning, and hyper-scale data science. With over 400 AbCellerites and growing, we’re expanding our capabilities to include CMC development and GMP manufacturing of antibodies to bring therapies from idea to patients, faster.
The will provide documentation lifecycle management oversight (i.e. creation, revision, issuance, tracking, storage, archiving, destruction, etc.) and DMS/eDMS system management for controlled documents used in conjunction with AbCellera’s CMC Development and Clinical Manufacturing operations. The role will also be responsible for GxP record archiving/maintenance of on-site/off-site storage locations as well as generating metric reports to be used to support management review.
We’re offering a generous compensation package including an equity stake in AbCellera’s success. Our future facility will be nestled in the heart of Vancouver, Canada - we’ll support you and your family in every way we can to relocate if you haven't had the joy of living in this beautiful area!
We’d love to hear from you if
- You are enthusiastic about applying your knowledge and experience in quality assurance documentation and record management
- You are strongly self-motivated and are able to work in fast paced environment
- You are a superior communicator and teammate
- You have a bias towards innovation over industry standards
How you might spend your days
- Maintaining a GxP compliant Documentation Management System (paper-based DMS and/or digital eDMS, as applicable)
- Supporting the editing of GxP-controlled documents in accordance with approved procedures and templates
- Coordinating the document review and approval workflows and with GxP Training Coordinator(s)
- Providing documentation lifecycle management support for the issuance, retrieval, archiving and/or destruction of controlled GxP documents in accordance with approved procedures and document/record retention schedule and archiving requirements
- Generating metric reports on Quality eDMS/DMS applicable metrics for periodic management review and to help drive Continuous Improvement
- Supporting regulatory health inspections and/or internal/external audits
Required qualifications and experience
- Bachelor's degree in a relevant discipline and 3+ years of industry experience working within a QA Documentation Control and/or Quality Systems related function. Bio/Pharmaceutical industry experience is preferred
- Experience with both paper-based and electronic Document Management Systems (DMS/eDMS)
- Superior attention to detail, technical and procedural writing skills when preparing and revising/reviewing documentation
- Strong interpersonal skills with the ability to work collaboratively as a member of cross-functional team, as well as independently
- Working or educational knowledge of cGMP, USP, ICH, EP and FDA guidelines, Good Documentation Practices (ALCOA+ principles) and data integrity requirements
At AbCellera, we find the next generation of therapeutic antibodies. To succeed, we have created innovative solutions at every step - custom antigen preparation and immunizations, microfluidics, high-throughput imaging, genomics, computation, machine learning and laboratory automation - leaving no stone unturned and revolutionizing how scientists can explore natural antibody diversity and the scale at which they can do it. You’ll join a diverse and multi-disciplinary team of biologists, biochemists, engineers, bioinformaticians, computer scientists and physicists - all working together to bring better therapies to patients. This is life-changing research and you could be a part of it.
We’re a growing company with state-of-the-art discovery tools and the drive to be the best in the industry. This isn’t just about having the best technology. We know we need a world-class team of innovators working together to solve the toughest problems. 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. We’re looking for someone like you to support and organize our efforts along the way.
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