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Senior Quality Assurance Specialist

LocationVancouver, British Columbia
Job ID R0001469 Date posted 03/04/2019

Job Description Summary

The Senior Quality Assurance Specialist role at STEMCELL assists in the development, implementation and maintenance of Business Operations 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.
  • Conduct internal and external audits to measure compliance to relevant standards, directives, regulations and policies.
  • Create and manage all key QMS programs such as 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 processes involved in the product life cycle.
  • Create and lead training initiatives specific to quality and regulatory.
  • Support Supplier Relationship with increased compliance requirements.
  • Lead multi-disciplinary projects to support corporate initiatives.
  • Identify and evaluate gaps in the QMS that cause risk to the business.
  • Support the Quality and Regulatory team in day to day activities.
  • Support QA system/systems ensuring an effective balance of compliance and efficiency..
  • 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.
  • Apply critical thinking to continuously improve product release processes.
  • Identify and evaluate gaps in the QMS that cause risk to the business.
  • Assisting with Quality Agreements review.
  • Provide leadership to all staff as related to quality practices and requirements.
  • Support the Quality team in day to day activities
  • 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

Qualifications:

  • Master’s or Bachelor’s Degree or Technical Diploma in a relevant field.
  • 10+ years’ experience in quality assurance and/or regulatory in the biotech industry or equivalent.
  • In depth knowledge of regulatory requirements (e.g., ISO 13485:2003, CE medical and IVD device directives, cGMP, etc.) is required. Recognized as a subject matter expert within the organization. High level of critical thinking.

Knowledge, Skills and Abilities (KSAs):

  • 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
  • High level of critical thinking.
  • Recognized as a subject matter expert within the organization.
  • 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.
  • Ability to question and not always be satisfied with the status quo;
  • Comfortable making presentations before groups;

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!

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