QA Specialist - Learning & Document Management (18-Month Contract) at AbCellera

Vancouver, British Columbia, Canada -

Full Time

Start Date

Immediate

Expiry Date

23 Jan, 26

Salary

95300.0

Posted On

25 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Biotech, Pharmaceutical, eDMS, LMS, GxP Training, Training Management, Document Management, Regulatory Compliance, cGMP, Health Canada, FDA, EU, ICH Requirements, Interpersonal Skills, Data Integrity

Industry

Biotechnology Research

Description

From target to the clinic. AbCellera’s platform integrates biology, computation, and engineering to develop impactful antibody-based medicines. We’re scientists, engineers, and business professionals who work together to turn scientific insights into breakthrough medicines. We pursue truth and scientific rigor. We think independently, act with conviction, and have the courage to work at the edge of the unknown. We offer the opportunity to stretch and explore, and to work on things that matter. We are looking for an enthusiastic QA Specialist to join our Quality Assurance Operations Learning Management Team. You will be responsible for supporting the GxP training programs at AbCellera, working closely with Training Owners, Training Administrators, Department Heads, and other stakeholders to support the identification of training needs, develop training content, manage the Learning Management System (Vault Training), and monitor training effectiveness. How you might spend your days Acting as the Training and Business Administrator in the eLMS, verifying training reports, and maintaining training records Assisting in the administration and management of GxP training courses in Vault Managing training impact assessments, quiz creation, and roll-out of training for GxP documents Contributing to the review, approval, and implementation of training content Reviewing and approving documents for adherence to internal training standards Driving the document change control process related to QMS/DMS/LMS Supporting daily operations within document/records management (paper-based and electronic) Assisting in establishing and maintaining standards and procedures for GxP training and GxP document management Supporting the periodic review of documents to ensure continued compliance Contributing to the development and implementation of logistical and administrative business processes to ensure compliant training program management Supporting regulatory health authority inspections and internal audits Generating KPI reports on LMS applicable metrics for periodic Quality Management Reviews We’d love to hear from you if You have a strong background in Quality Assurance within the biotech/pharmaceutical industry You have worked within a qualified eDMS and/or LMS system (e.g. Veeva) 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 thrive working in a fast paced environment and 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, technology, 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 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 focused on delivering breakthrough medicines that alleviate suffering, extend lives, and improve health. Our platform includes fully integrated capabilities to create first-in-class and best-in-class antibody medicines, from discovery to clinical manufacturing. We are using our technological advantage to develop programs across multiple indications including endocrine and metabolic conditions, oncology, and inflammation and autoimmunity. We’re advancing programs involving complex transmembrane proteins, bispecifics, and antibody drug conjugates. Creating medicines is the most important work we can do. 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 23316 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. All communication from our Talent Discovery team will come from an @abcellera.com email address. #LI-LC1 #LI-AS #LI-MS

Responsibilities

The QA Specialist will support GxP training programs, manage the Learning Management System, and monitor training effectiveness. Responsibilities include maintaining training records, assisting in training course management, and supporting document management operations.