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Compliance Specialist
2 weeks ago
**Job Description Summary**:
Here at STEMCELL Technologies the Reliability Engineering team is expanding and we are looking for a Compliance Specialist to join us This role will represent the Facilities and Equipment team in compliance discussions with other departments and will be a key educator for facility and equipment compliance in regulated environments globally, while staying up to date on current regulatory industry trends and development.
As a Compliance Specialist, you will be responsible for developing and facilitating the regulatory compliance of STEMCELL’s Building Systems and Equipment program globally. This role will work closely with the Managers of Planning and Scheduling, Building Systems, and Equipment Maintenance and Qualification, to develop, implement, and maintain the highest compliance of the applicable regulations and standards for STEMCELL Technologies.
**Duties and Responsibilities**
- Lead investigation and documentation activities for deviations, non-conformances, risk assessments, impact assessments, and proposed change controls
- Perform documentation life cycle activities (creation, revision, retirement) in the corporate Quality Management and Document Management Systems
- Perform peer/departmental reviews of executed qualification documentation. Assist with auditing facility processes for regulatory compliance
- Coordinate Facilities/Equipment activities related to internal and customer audits including department responses, preparation of data for audits such as trends and analysis for reporting
- Contribute towards the development and maintenance of KPIs within the Facilities and Equipment team to assess and monitor compliance, and support the development of training program related to regulatory compliance for the Facilities and Equipment team
**Knowledge and Qualifications**
- Bachelor’s degree in science or technical diploma in a relevant field with 6-10 years of experience working in a regulated environment in a similar role (quality control, quality assurance, facilities, etc.)
- Experience with regulatory requirements (e.g. ISO 13485, CE medical and IVD device directives, cGMP, etc)
- Compliance-minded, results and detail-oriented, with strong problem solving and analytical skills
- Excellent written and verbal communication skills
**#United #LI- Hybrid**
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 meaningful career development opportunities.
STEMCELL is well recognized for exceptional leadership and business practices. We are one of Canada’s Best Managed Companies and operate an ISO 14001-certified environmental management system to measure and reduce our environmental impact.
As an equal opportunity employer, STEMCELL is dedicated to ensuring that every employee feels safe, valued, and respected for who they are. We know that scientific progress and innovation occur when diverse, creative minds come together and we are committed to nurturing a culture of inclusivity and belonging. STEMCELL enforces a zero-tolerance policy for any form of discrimination. Selection decisions are solely based on job-related factors.
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