Senior Quality Assurance Specialist, Product Release

Summary

Calling all scientifically-driven individuals! Join our dynamic team at STEMCELL, where we lead the way in regulated product development within the biotechnology, pharmaceutical, and life sciences fields. If you have experience in GMP and a passion for excellence, this is the opportunity for you.

As a key member of our team, you will take charge of regulated product batch releases and play a crucial role in the end-to-end process of GMP New Product Introduction (NPI) projects. We value Quality, Integrity, and Innovation above all else, which is captured in every element of our Quality Management System at the batch level.

Duties and Responsibilities

• Oversee record reviews, ERP-based releases, investigations, deviations, and line clearance
• Represent Quality Assurance (QA) for cross-functional meetings
• Review, verify and process of QMS records to ensure compliance to QMS standards such as ISO 9001/13485/relevant GMPs, and established procedures
• Developing and maintaining training materials
• Proactively collaborate to identify any investigations and solutions

Knowledge And Qualifications

• Bachelor's degree in a related field, with a minimum of six years of experience within a regulated environment
• GMP experience in biotechnology, pharmaceutical or life science field is a must
• Thorough understanding of regulatory, corporate, and customer requirements
• Extensive knowledge of Quality System regulatory requirements, including 21 CFR 820, 21 CFR 210 and 211
• Ability to prioritize, manage, and coordinate tasks in a dynamic environment

#Nonbench

STEMCELL Technologies 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 boosters), as currently recommended or required by local health authorities and public health orders, unless an exemption from this policy is approved through our accommodation request process.

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