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
The Compliance Coordinator, Facilities is responsible for supporting the Manager of Facilities Compliance in developing, monitoring and tracking the progress of compliance initiatives and ongoing compliance-related activities and operations within the Facilities Department at STEMCELL to meet applicable regulatory regulations and standards.
Duties and Responsibilities
Coordinate Facilities activities related to compliance deliverables for various projects.
Perform peer/departmental reviews of executed qualification documentation.
Support Facilities by coordinating document life cycle activities (creation, revision, retirement) in the corporate Quality Management and Document Management Systems.
Support technical writing efforts by revising or creating procedures and writing summary reports for executed qualification studies.
Support and/or represent Facilities in compliance discussions with other departments.
Coordinate investigation and documentation activities for deviations, non-conformances, risk assessments, impact assessments and proposed change controls.
Coordinate Facilities activities related to internal and customer audits including coordination of department responses.
Coordinate and participate in Facilities driven compliance assessments and self-audits to support continuous improvement activities.
Support the development and maintenance of metrics related to compliance within the Facilities team.
Support the development, deployment, and ongoing operation of a departmental training program.
Coordinate cross-functional meetings related to Facility projects and compliance-related deliverables.
Complete minutes for team meetings.
Track team deliverables to completion.
Support the Facilities department in day to day activities.
- University degree in science or technical diploma in a relevant field.
5+ years experience working in a regulated environment (quality control, quality assurance, facilities, etc.).
Familiarity with regulatory requirements (e.g. ISO 13485, CE medical and IVD device directives, cGMP, etc.) is desired.
Compliance-minded, highly goals driven and detail-oriented.
Good interpersonal skills; self-motivated.
Excellent written and verbal communication skills.
Ability to multi-task in a rapidly changing and expanding environment.
Strong work ethic with a willingness to learn and assume new responsibilities.
Advanced knowledge of Microsoft Word, PowerPoint, Excel.
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!