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Quality Control Specialist, Cell Core
2 weeks ago
**Job Description Summary**:
Are you prepared to advance your career in Quality Control and have the opportunity to join a team that is responsible for the production, cell characterization, and quality assessment of cell banks?
You will also be responsible for conducting intricate investigations and root cause analyses for company projects, as well as collaborating with external partners to assist our esteemed partners. Your proficiency in GMP testing methods will establish you as a trusted authority to verify the quality of our biologics portfolio, supporting the advancement of cell and gene therapy products. Moreover, you will play a crucial role in cross-departmental initiatives, ensuring seamless communication and coordination.
**Duties and Responsibilities**
- Provide a quality perspective with developing SOP, laboratory reports, aseptic techniques, and quality documentation
- Serve as an SME for cell banking and developing and troubleshooting cell characterization assays
- A core collaborator with valued internal and external partners, who will clearly communicate and disseminate information
- A strong sense of independence and ownership with projects, with an adaptability with changing priorities
- Flexibility with working outside regular hours, including weekends as needed to meet business needs
**Knowledge and Qualifications**
- A minimum of a Bachelor's Degree is a life-science related discipline, with two years in a GMP environment
- Flawless aseptic technique in mammalian cell culture is required such as CHOs cells or PSC cells
- Previous GMP practices that can be extended to this role
- Experience with Quality Management Systems, and interpreting regulatory documents such as CFRs, USP, FDA, and ICH guidance documents
- A comprehensive knowledge of Product Lifecycle Management (PLM) and prior experience in New Product Introduction (NPI) is essential
Bench #LI-Onsite #LI-ML1
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.
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