Quality Assurance Associate, Systems
Job Description Summary
The Quality Assurance Associate role at STEMCELL assists in the maintenance of the STEMCELL 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 implementing best industry processes in a fast changing environment.
Duties and Responsibilities
- Assist in maintaining the corporate wide Quality Management System (QMS) required for the manufacture and distribution of STEMCELL products which include RUO and regulated products.
- Support the Supplier Qualification Program through sending, receiving and assessing supplier questionnaires.
- Assist with managing/responding to customer requests for questionnaires as well as managing documentation related to the corporate Change Notification Program.
- Support the Audit program through compilation and management of audit files as well as monitoring timely completion of audit corrective actions.
- Support the Change Control Program and requests for temporary changes
- Review and approve internal controlled documents such as Standard Operating Procedures, Work Instructions, forms, etc.
- Apply good documentation practices to all documents created and/or reviewed.
- Perform ERP transactions related to QMS processes.
- Collaborate with internal teams to represent compliance requirements
- Apply critical thinking to continuously improve QMS processes.
- Support the Quality team in day to day activities.
Education: Bachelor’s Degree or Technical Diploma in relevant field.
Experience: 2-4 years’ experience in quality assurance in the biotech or healthcare industry or equivalent.
Specialized knowledge: Knowledge of regulatory requirements (e.g., ISO 13485:2016, 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.
- Self-motivated and independent work ethic.
- Ability to question and not always be satisfied with the status quo.
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!