Formation et qualification:
- 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.
Tâches et responsabilités:
- 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.
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. If you are interested in this challenging and rewarding position, please apply online at https://jobs.stemcell.com/