Quality Assurance, Product Release Associate
STEMCELL Technologies Inc. is a privately-owned biotechnology company based in Vancouver that helps power leading-edge life science research around the world. Scientists performing stem cell, immunology, cancer, regenerative medicine and cellular therapy research are among those who rely on our cell culture media, cell separation products, instruments, ancillary reagents and contract assay services. We create novel, useful, standardized products of unfailing quality and deliver them to more than 70 countries via our many regional offices plus distribution centres in Vancouver, Seattle, Grenoble and Singapore. Driven by our love of science and our passion for quality, we see ourselves simply as “Scientists Helping Scientists” – standing by our customers to provide outstanding products, technical support and training. We have over 1000 science-oriented employees globally, including 250 PhDs/MScs, with most others holding a BSc or engineering degree. STEMCELL is proud to be the largest Biotechnology employer in Canada.
Job Description Summary
QA is looking to fill a position for QA Product Release Associate. The Quality Assurance Product Release Associate role at STEMCELL assists in the maintenance of the STEMCELL Quality Management System (QMS), compliance to applicable regulations, and executes review and approval of materials for product release. It gives the opportunity to exercise independent judgment in evaluating complex problems and applying current methodologies and practices to resolve identified issues. STEMCELL is a dynamic workplace that pursues cutting edge technologies and practices which translates to implementing best industry processes in a fast changing environment.
ROLES AND RESPONSIBILITIES
- Assist in maintaining the corporate wide Quality Management System (QMS) required for the manufacture and distribution of STEMCELL products which include RUO, GMP, and regulated products.
- Support Key Relationship Management Accounts with increased regulatory requirements.
- Investigate and understand all processes involved in the product lifecycle.
- Review of Certificates of Analyses, Quality reports, batch records and other related product documentation required for product release.
- Apply good documentation practices to all document review.
- Perform ERP transactions related to product release.
- Co-ordinate Quality interactions with Suppliers and ongoing Supplier monitoring to ensure accuracy of documentation and efficiency of product release.
- Collaborate with internal teams to represent compliance requirements related to document review and product release.
- Apply critical thinking to continuously improve product release processes.
- Edit and write Standard Operating Procedures.
- Support the Quality team in day to day activities.
- Support all key QMS programs such as but not limited to Change Control, Product Change Form, CAPA, Training, Documents and Records, Specifications, etc.
- Prepare, review, implement and improve procedures and processes across the organization to align with corporate initiatives and strategies.
- Participate in multi-disciplinary projects to support corporate initiatives.
- Bachelor’s Degree in relevant field.
- Experience: 4+ years’ experience in quality assurance and/or regulatory in the biotech industry or equivalent.
- Specialized knowledge: Knowledge of regulatory requirements (e.g., ISO 13485:2003, CE medical and IVD device directives, cGMP, etc.) is required.
Knowledge, Skills and Abilities (KSAs):
Proven ability to coordinate and execute responsibilities relating to Quality Assurance.
Excellent communication skills.
Good interpersonal skills.
Highly organized and detail oriented.
Willingness to learn and assume new responsibilities.
Ability to handle multiple tasks in a fast paced environment.
Aptitude for learning and working with various electronic/technology platforms.
Ability to understand and analyze technical documents, processes, regulations, industry standards, procedures and processes.
Self motivated and independent work ethic.
Ability to question and not always be satisfied with the status quo.
This is an opportunity to work with highly motivated colleagues in a science-oriented, creative and dynamic environment. We offer a competitive salary, excellent benefits and significant career development opportunities.