Job Description Summary
If you are a strong critical thinker looking to guide departmental policies, procedures, and processes, this Quality Assurance Specialist could be the opportunity for you!
By utilizing your scientific knowledge and quality background, your input will support STEMCELL in providing cutting edge technologies. You are a driven to develop our Quality Management System (QMS), ensuring that it is compliant to applicable regulations. Be proactive in It gives the exercising strong judgment in evaluating complex problems, and applying current methodologies and practices to resolve identified issues.Job Description Duties and Responsibilities
Knowledge and Qualifications
- Support and maintain the corporate-wide QMS required for the manufacture and distribution of STEMCELL products, which include non-regulated and regulated products
- Review, verify, and process QMS records to ensure compliance to Quality Management Standards such as International Organization for Standardization (ISO 9001/13485), relevant Good Manufacturing Practices (GMPs) and established procedures
- Provide recommendations to supervisor/manager regarding potential process improvements
- Manage low to moderately complex situations/scenarios that require critical thinking and reviews the impact to the department and to the organization
- May represent QA for cross-functional projects/initiatives/meetings and raise/discuss potential issues with the cross-functional team and supervisor/manager
- Bachelor's Degree in related field with a minimum of 3 years in relevant work, or Technical Diploma in related field with a minimum of 5 years in relevant work experience
- In depth knowledge of regulatory requirements (e.g., ISO 9001, ISO 13485, medical and in vitro diagnostic, cGMP, etc.) is required
- Ability to exercise a high level of critical thinking and analyze/evaluate situations using a risk based approach
- Good interpersonal skills, strong collaborator with excellent verbal and written communication skills
- Self-motivated and independent work ethic, with a willingness to learn and assume new responsibilities
This role requires being fully vaccinated against COVID-19 as per STEMCELL's vaccination policy, the current recommendations by local health authorities and as required by public health orders in place from time to time, including any COVID-19 boosters as recommended by local health authorities and as required by public health orders in place from time to time.
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!