The Quality Assurance Specialist role at STEMCELL assists in achieving and maintaining compliance to regulation during design, development and technology transfer of regulated products and for related facilities. 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 this role managing complex sources of data that require in-depth critical thinking and reviewing the impact to the department and organization.
Duties and Responsibilities
- Support product design, development and technology transfer activities including review and approval of related documentation.
- Create and/or verify execution of quality strategies supporting regulatory filings and requirements.
- Maintain the corporate wide Quality Management System (QMS) required for the manufacture and distribution of STEMCELL products which include CE-IVD, CE-EE, RUO and GMP products.
- Oversees QA system/systems ensuring an effective balance of compliance and efficiency.
- Conducts or supports investigations internally and externally using industry standard methods for root cause determinations and identification of meaningful corrective and preventative actions.
- Conduct internal and external audits to measure compliance to relevant standards, directives, regulations and policies.
- Prepare, review, implement and improve procedures and processes across the organization to align with corporate initiatives and strategies with a focus on Quality systems that support and utilize the company's products.
- Investigate and understand all processes involved in the product life cycle.
- Collaborate with multiple internal disciplines and external product, process and program teams to represent compliance requirements within the QMS.
- Create and lead training initiatives specific to quality compliance for ISO and or GMP products.
- Identify and evaluate gaps in the QMS that cause risk to the business.
- Support the Quality team in day to day activities.
- Master’s or Bachelor’s Degree or Technical Diploma in relevant field.
- 5+ years’ experience in quality assurance and/or regulatory and process improvement in the biotech industry or equivalent. Experience in design, development and tech transfer an asset.
- In depth knowledge of regulatory requirements (e.g., ISO 13485, CE medical and IVD device directives, cGMP, etc.) is required.
- High level of critical thinking.
- Proven ability to coordinate and execute responsibilities relating to Quality Assurance.
- Excellent technical report writing and strong ability to understand and analyze technical documents, processes, regulations, industry standards, procedures and processes.
- Excellent communication skills.
- Demonstrated ability in project management and time management to ensure completion of tasks on a priority basis.
- Willing to commit to occasional travel, approximately once a quarter (globally).
- Comfortable making presentations before groups.
- Ability to question and not always be satisfied with the status quo.
- Willingness to learn and assume new responsibilities.
- Good interpersonal skills; self-motivated and independent work ethic.
- Ability to handle multiple tasks in a fast paced environment.
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.
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.Apply Now