Job Description Summary
If you are a strong critical thinker looking to guide departmental policies, procedures, and processes, this Senior Quality Assurance Specialist could be the opportunity for you!
By utilizing your scientific knowledge and quality background, your input will support decisions pertaining to product releases, new product launches, and document approvals. This role requires complex decisions in consultation with our Research and Development, Quality Control, Regulatory Affairs, and Technical Operations Teams. You will proactively identify compliance risks while designing, developing, and approving reports, ensuring the accuracy and completeness of documentation.Job Description Duties and Responsibilities
Knowledge and Qualifications
- Review, verification, processing of QMS records to ensure compliance to Quality Management Standards such as ISO 9001, ISO 13485, relevant GMPs and established procedures
- Identify compliance and process issues/gaps to supervisors/managers. Proactively collaborate with stakeholders to identify any investigations and solutions
- Ability to prioritize, manage, and coordinate day to day tasks and escalate to managers as required
- Responsible for the development and delivery of formal training material, activities, and maintenance of existing training materials
- Represent QA for cross-functional projects and meetings, serving as a Quality educator, and discussing potential issues with the cross-functional team and manager
- At least 6 years' experience combined in quality unit and manufacturing in the biotech regulated industry or equivalent
- GMP experience in biotechnology, pharmaceutical, or life science field is required
- Extensive knowledge of Quality System regulatory requirements, including 21 CFR 820, 21 CFR 210 and 211
- Excellent communication skills, with a drive to foster collaboration
- Willing and able to travel once per quarter to conduct audits
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 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.
NOTE: STEMCELL's vaccination policy requires that all candidates for this role be fully vaccinated against COVID-19 (including with boosters) against COVID-19, as currently recommended or required by local health authorities and public health orders.
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