Senior Quality Assurance Specialist
Job Description Summary
The Senior Quality Assurance Specialist role at STEMCELL assists in the development, implementation and maintenance of Business Operations Products under STEMCELL’s Quality Management System (QMS) and compliance to applicable regulations. 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 in managing complex sources of data that require in-depth critical thinking and reviewing the impact to the department and organization.
Duties and Responsibilities
- 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.
- Create and manage all key QMS programs such as but not limited to Change Control, CAPA, Documents and Records, Specifications, etc.
- 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.
- Provide leadership to all staff as related to quality practices and requirements.
- 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.
- Support supplier relationships with increased compliance requirements.
- Review and archive IRB and ICF documents related to primary cell products.
- Support QA system/systems ensuring an effective balance of compliance and efficiency.
- Manage Quality interactions with suppliers and ongoing supplier monitoring to ensure accuracy of documentation.
- Apply critical thinking to continuously improve product release processes.
- Lead multi-disciplinary projects to support corporate initiatives.
- Identify and evaluate gaps in the QMS that cause risk to the business.
- Lead/Assisting with Quality Agreements review.
- Support the Quality team in day to day activities.
- Review of Certificates of Analysis, 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.
- Master’s or Bachelor’s Degree in relevant field.
- 10+ years’ experience in quality assurance and/or regulatory and process improvement in the biotech industry or equivalent.
- In depth knowledge of regulatory requirements (e.g., ISO 13485:2003, CE medical and IVD device directives, cGMP, 21 CFR 50 and 56 IRB Regulations, 21 CFR 1271 Human Cells, Tissues and Cellular and Tissue Based Products, Human Tissue (Quality and Safety for Human Application) Regulations 2007 and Human Tissue Act (2004) Human Tissue Act (EU)) is required.
- Recognized as a subject matter expert within the organization.
- 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.
- Exercises judgment within undefined practices and procedures that may be incomplete or complex.
- 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.
- Knowledgeable in HIPAA; certification is desired.
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.
To apply please select the apply button. You will then be directed to a login screen asking you to set up an account. You must set up an account in order to apply.
Create an account by selecting the create account button. You will then be asked for your email and to create a password. Your Password must be eight characters long, contain at least one special character, one capital letter, and a number.Once you have created your password you will be asked to upload your resume. Uploading your resume will provide the ability to auto-populate your application with information from your resume. If you prefer to manually complete all of the fields in the application you can do this by clicking next. You can upload your cover letter as an attachment in the attachments screen. Thank you for your interest in STEMCELL!