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STEMCELL Technologies

Quality Assurance Specialist

Location
Burnaby, BC
Details
Full Time
6 hours ago
Job Description Summary

The Quality Assurance Specialist role at STEMCELL assists in the development, implementation and maintenance of Private Label and Distributed Products under STEMCELL's 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 this role managing complex sources of data that require in-depth critical thinking and reviewing the impact to the department and organization.

Job Description

Duties and Responsibilities
  • Maintain the corporate-wide Quality Management System (QMS) required for the manufacture and distribution of STEMCELL products manufactured under ISO and other regulatory requirements.
  • Conduct internal and external audits to measure compliance to relevant standards, directives, regulations and policies.
  • Create and manage all key QMS programs including but not limited to Change Control, CAPA, Documents and Records, Specifications, etc.
  • Prepare, review, implement and improve procedures and processes across the organization to align with corporate initiatives and strategies.
  • Investigate and understand all the processes involved in the product life cycle.
  • Identify and evaluate gaps in the QMS that cause risk to the business.
  • Coordinate Quality interactions with Suppliers and ongoing Supplier monitoring to ensure accuracy of documentation.
  • Collaborate with internal teams to represent compliance requirements related to document review and product release.
  • Support the Quality and Regulatory team in day to day activities.
  • Apply good documentation practices to all document reviews.
  • Perform ERP transactions and review Certificates of Analyses, Batch Records and other related product documentation required for product release.


Qualifications
  • Master's or Bachelor's Degree in the relevant field.
  • 5+ years' experience in quality assurance and/or regulatory in the biotech industry or equivalent.
  • Working knowledge/experience of key regulatory requirements (e.g ISO 13485, CE medical and IVD device directives, cGMP, etc.).
  • Proven ability to coordinate and execute responsibilities relating to Quality Assurance .
  • Excellent technical report writing and strong ability to understand and analyze technical documents, processes, regulations, industry standards, procedures and processes.
  • Exercises judgment within undefined practices and procedures that may be incomplete or complex.
  • Demonstrated ability in project management and time management to ensure completion of tasks on a priority basis.
  • Comfortable making presentations before groups.
  • Excellent communication and interpersonal skills.
  • Highly organized and detail-oriented.
  • Aptitude for learning and working with various electronic/technology platforms.
  • Ability to question and not always be satisfied with the status quo.
  • Willing to commit to occasional travel globally (minimum 20%).


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.

#NonBench

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.

To apply please select the apply button. You will then be directed to a login screen asking you to set up an account. You must set up an account in order to apply.

Create an account by selecting the create account button. You will then be asked for your email and to create a password. Your Password must be eight characters long, contain at least one special character, one capital letter, and a number. Once you have created your password you will be asked to upload your resume. Uploading your resume will provide the ability to auto-populate your application with information from your resume. If you prefer to manually complete all of the fields in the application you can do this by clicking next. You can upload your cover letter as an attachment in the attachments screen. Thank you for your interest in STEMCELL!
Category
Quality Assurance