Job Details

Quality Assurance Associate, Product Release

Title
Quality Assurance Associate, Product Release
Length
Contract
Employer

STEMCELL Technologies

Salary
not disclosed
Location
Vancouver
British Columbia
Date Posted
02/08/2018 - 14:45
Closing Date
02/09/2018 - 14:45
Accepting BioReady
Yes
Job Description
Summary: 

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.

Job Description Summary

The Quality Assurance Associate role at STEMCELL assists in the maintenance of the STEMCELL Quality Management System (QMS) and compliance to applicable regulations. It gives the opportunity to exercise independent judgment in evaluating complex problems and applying current methodologies and practices to resolve identified issues. STEMCELL is a dynamic workplace that pursues cutting-edge technologies and practices which translates to implementing best industry processes in a fast changing environment.

Education & Qualifications: 

Education:  Bachelor’s Degree or Technical Diploma in relevant field.

Experience: 5+ years’ experience in quality assurance and/or regulatory in the biotech industry or equivalent.

Specialized knowledge:  Knowledge of regulatory requirements (e.g., ISO 13485:2003, CE medical and IVD device directives, cGMP, etc.) is required.

Knowledge, Skills and Abilities (KSAs):

  • Proven ability to coordinate and execute responsibilities relating to Quality Assurance
  • Excellent communication skills.
  • Good interpersonal skills.
  • Highly organized and detail oriented.
  • Willingness to learn and assume new responsibilities.
  • Ability to handle multiple tasks in a fast paced environment.
  • Aptitude for learning and working with various electronic/technology platforms.
  • Self-motivated and independent work ethic.
  • Ability to question and not always be satisfied with the status quo.
Duties & Responsibilities: 
  • Assist in maintaining the corporate-wide Quality Management System (QMS) required for the manufacture and distribution of STEMCELL products which include RUO and regulated products.
  • Review of Certificates of Analyses, Batch Records and other related product documentation required for product release.
  • Apply good documentation practices to all document review.
  • Perform ERP transactions related to product release.
  • Co-ordinate Quality interactions with Suppliers and ongoing Supplier monitoring to ensure accuracy of documentation and efficiency of product release.
  • Collaborate with internal teams to represent compliance requirements related to document review and product release.
  • Apply critical thinking to continuously improve product release processes.
  • Edit and write Standard Operating Procedures.
  • Support the Quality team in day to day activities.
Other Information: 

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.  If you are interested in this challenging and rewarding position, please visit our website at https://jobs.stemcell.com/ to apply.