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Quality Assurance Associate

Organization

Canada's Michael Smith Genome Sciences Centre

Job Location

100-570 West 7th Ave.
Vancouver BC V5Z 4S6
Canada

Job Description

Job Reference No: RPC-R00022-2021-05-07

BC Cancer has an opening for a full time Quality Assurance Associate. The Quality Assurance Associate will assist in the coordination and administration of the Quality Management System for the Cancer Immunotherapy Program at the BC Cancer's Deeley Research Centre (DRC) in Victoria, BC. This position can be based in Vancouver, B.C. or Victoria, B.C.

These duties include, but are not limited to, document control, nonconformance and corrective/preventative actions, instrument calibration/preventive maintenance, vendor management, material and equipment risk assessments, quality system training, compiling documentation for regulatory submissions and other activities as appropriate to maintain GMP compliance for the BC Cancer ‘s Cancer Immunotherapy Program.

The Quality Assurance Associate receives guidance from and reports to, BC Cancer's Cancer Immunotherapy Program's Quality Manager or delegate.

Key Accountabilities:

  • Maintaining and controlling documents and records, ensuring only current and active documents are used, and obsolete or superseded ones are archived appropriately.
  • Performing document control tasks such as documentation completeness verification and release of approved documents.
  • Assisting in developing and conducting quality related training sessions for manufacturing, research and quality staff. Maintaining training records for all staff.
  • Overseeing and maintaining a comprehensive nonconformance /corrective and preventive action program. Assisting with root-cause investigations associated with deviations and non-conformances, and recommending follow-up and or/corrective actions. Ensuring nonconformance’s are completed in a timely manner and coordinates approvals.
  • Performing and approving vendor qualifications, conducting vendor risk assessments, maintaining an approved vendors list, maintaining vendor files and coordinating with vendors to receive updated certifications and material/service information.
  • Reviewer for equipment installation qualifications, operation qualifications and performance qualifications.
  • Helps prepare documentation for regulatory submissions, as required by the Head of Regulatory and Quality.
  • Participates in Point of Care (POC) cell Manufacturing Network initiatives for the production of CLIC (Canadian Lead Immunotherapies in Cancer) CAR-T cells throughout Canada.  
  • Participating in internal and external audits as needed.
  • Performing other related duties as assigned.

Requirements

Education, Training and Experience

  • A Bachelor's degree from a recognized university in Biology, Chemistry, Molecular Biology or a related discipline.
  • Minimum three (3) years of experience in Quality Management Systems with particular experience in the following processes:
    • vendor management,
    • risk assessments, and
    • nonconformance’s/corrective and preventive actions.
  • Standards and regulatory knowledge with GMP, FACT, ISO 13485, ISO 14971, FDA 21 CFR 820 and/or Health Canada’s Requirements.
  • Knowledge of the clinical trials regulatory environment in Canada, cell therapy, immunology, and/or immunotherapy would be an asset.

Skills and Abilities

  • Demonstrated ability to accept responsibility and work independently.
  • Demonstrated ability to work effectively with others in a team environment.
  • Demonstrated ability to organize work and establish priorities.
  • Demonstrated ability to communicate effectively both orally and in writing.
  • High attention to detail, excellent organizational and time management skills and clear, concise writing and proof-reading skills.
  • Proficiency in relevant software applications, such as Word and Excel. Knowledge and experience in document control software (e.g. QPulse) would be an asset.

Terms of Employment

  • May be required to work extended hours, weekends and holidays
  • May be required to travel between Vancouver and Victoria
  • May be required to perform work outside scope of responsibilities, as needed​

How to Apply

Please submit a detailed cover letter and resume to [email protected] using "Quality Assurance Associate" in the subject line of your email.

This posting remain online until filled.

About Our Organization

Canada’s Michael Smith Genome Sciences Centre (GSC)

Today’s Research. Tomorrow’s Medicine.

The GSC is a department of the BC Cancer Research Institute and a high-throughput genome sequencing facility. We are leaders in genomics, proteomics and bioinformatics in pursuit of novel treatment strategies for cancers and other diseases.

Among the world’s first genome centres to be established within a cancer clinic, for more than two decades our scientists and innovators have been designing and deploying cutting-edge technologies to benefit health and advance clinical research.

Among the GSC’s most significant accomplishments are the first publication to demonstrate the use of whole-genome sequencing to inform cancer treatment planning, the first published sequence of the SARS coronavirus genome and major contributions to the first physical map of the human genome as part of the Human Genome Project.

By joining the GSC you will become part of an exceptional and diverse team of scientists, clinicians, experts and professionals operating at the leading edge of clinical research. We look for people who share our core values—science, timeliness, respect—to join us on our mission to use genome science for the betterment of health and society.