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 Senior Specialist, Document Management Systems will support the preparation of the document management plan/strategy for eDMS/DMS implementation and the oversight of the lifecycle (creation, revision, issuance, tracking, storage, archiving, destruction, etc.) of controlled documents used to support Quality Systems & Compliance for CMC and GMP manufacture of monoclonal antibodies. The role will also be responsible for establishing and generating documentation metrics, establishing record retention schedules, creating training materials for the eDMS/DMS and providing the training to new and existing team members. Freedom will be given to innovate and move at lightning speed to create a legacy in our industry.
We’d love to hear from you if
- You are strongly self-motivated and are able to identify Quality documentation needs and follow that up with creating and implementing solutions
- You are passionate about building quality programs and capabilities that accomplish important goals
- You have a bias towards innovation over industry standards
- You are enthusiastic about applying your knowledge and experience in quality assurance documentation management
- You have the ability to identify and define phase-appropriate CMC and GMP Quality documentation and records (eDMS/DMS i.e. electronic/paper-based) needs
- You are an superior communicator and teammate
How you might spend your days
- Creating, implementing and maintaining a document control system and filing and archiving plan/strategy for CMC and GMP documentation (eDMS/electronic and paper, as applicable)
- Creating and revising company standard operating procedures and reviewing GMP-controlled documents, as necessary, including assessing where new controlled documents fit within the QMS
- Providing reports to management and project management regarding implementation of eDMS/DMS
- Developing, compiling and reporting on Quality eDMS/DMS applicable metrics for periodic management review
- Ensuring the maintenance of documents and records in accordance with the required record retention schedule and archiving requirements
- Participating in resolving deviations associated with the eDMS/DMS
- Working directly with QA and other AbCellera departments to create, revise, issue, track and manage controlled documents to meet timelines
- Processing, distributing, maintaining, tracking and archiving controlled documentation (e.g. SOPs, Batch Records, material specifications, etc.) using an eDMS/DMS
- Conducting internal audits of AbCellera’s systems and documents, where needed, to ensure compliance to applicable AbCellera’s policies and SOPs related to records and documentation
- Supporting regulatory (Health Canada, FDA, EMA) and partner audits/inspections of AbCellera, as well as issuing batch production records
- Providing training to AbCellera team members on the eDMS/DMS and procedure management, as required
- Supporting the selection and establishment of the Learning Management System, as needed
- Continuously driving improvements to the established processes, increasing speed and efficiency while meeting regulatory requirements
Required qualifications and experience
- A Bachelors or Masters degree in a relevant discipline and 8+ years of industry experience working within quality assurance documentation control
- 4+ years of experience within the Quality Assurance department, preferably within Quality Systems (eDMS/DMS)
- Superior attention to detail, technical and procedural writing skills when preparing and revising/reviewing documentation
- Superior grammatical accuracy and completeness when creating and revising documents
- Outstanding organizational skills to ensure the eDMS/DMS is established as required and remains in a state of control
- Experience in executing deliverables from annual QA plans, on-time and at the required quality level
- Excellent communication and presentation skills with an ability to adjust to both technical and non-technical audiences
- Results oriented, and able to effectively execute on projects with minimal supervision
- Exposure to 21 CFR Parts 210 & 211, biotechnology, Process Development (PD) and electronic validated computer systems a plus
- A good understanding of the drug development processes from discovery through CMC development, with an ability to understand business documentation requirements and translate them into practical solutions
- Strong interpersonal skills with the ability to work collaboratively as a member of cross-functional team, as well as independently
What We Offer
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!
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.