Senior Equipment Compliance Associate
Job Description SummaryThe Senior Equipment Compliance Associate is responsible for developing and facilitating regulatory compliance of STEMCELL’s facilities and equipment program globally, working closely with the Managers, Facilities/Equipment. This role is integral in supporting the Facilities/Equipment Team’s efforts to develop, implement and maintain the highest compliance of the applicable regulations and standards and serves as an information resource to STEMCELL staff when guiding and navigating the increasingly complex regulatory compliance requirements. This role is also responsible for independently leading, tracking and reporting on the progress and successful delivery of new, existing and ongoing regulatory compliance project initiatives and activities, including training as assigned.
Duties and Responsibilities:
Serve as a key resource for facility and equipment compliance in regulated environments globally.
Research and recommend solutions that meet regulatory compliance requirements. Stay up-to-date on current regulatory industry trends and developments.
Represent Facilities/Equipment in compliance discussions with other departments and escalate as needed.
Lead investigation and documentation activities for deviations, non-conformances, risk assessments, impact assessments and proposed change controls.
Participate in or perform Facilities-driven compliance assessments and self-audits to support continuous improvement activities.
Perform documentation life cycle activities (creation, revision, retirement) in the corporate Quality Management and Document Management Systems.
Author technical documents such as revising and creating procedures and writing summary reports for executed qualification studies.
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/Equipment team to assess and monitor compliance.
Support the development, deployment, and ongoing operation of a departmental training program related to regulatory compliance for the Facilities/Equipment team.
Apply project management methodologies to lead Facilities/Equipment activities related to compliance deliverables for various projects. Track team deliverables to completion.
Support the Facilities/Equipment department in day-to-day activities. Perform other duties as assigned.
May be required to complete and maintain necessary training to work with both regulated and non regulated products.
May be required to provide technical expertise and knowledge to other departments related to regulated and non-regulated products.
Bachelor’s degree in science or technical diploma in a relevant field.
5+ 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, 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 role requires vaccination against COVID-19 as per the current recommendations by local health authorities, including any COVID-19 boosters as recommended by local health authorities and where available.
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.
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