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Quality Control Specialist

Job Code: QCS 11-14-2018

The Quality Control Specialist will support the manufacturing, quality control and quality assurance activities for BC Cancer's Cancer Immunotherapy Program, at BC Cancer's Deeley Research Centre (DRC) in Victoria. These systems include, but are not limited to, performing and validating quality control assays, instrument calibration/preventive maintenance, monitoring and trending quality control data, and other activities as appropriate to maintain GMP compliance for the DRC’s T-cell manufacturing facility. The Quality Control Specialist receives guidance from and reports to, BC Cancer's Cancer Immunotherapy Program's QA Manager.

Key Accountabilities

  • Assisting laboratory production staff in identifying quality control (QC) issues in manufacturing processes
  • Assisting in SOP and specification development by identifying and contributing QC-related material to production SOPs
  • Working with the QA Manager and the DRC T-cell manufacturing team to draft QC-related SOPs
  • Performing daily QC tasks and duties including the following:
    • Carrying out established QC assays according to Standard Operating Procedures (SOPs)
    • Maintaining formal documentation of laboratory processes
    • Maintaining validation and QC programs for instrumentation and procedures
    • Scheduling and prioritizing repair and preventative maintenance of laboratory equipment
    • Monitoring, trending and analyzing QC data and generating analysis reports
    • Communicating QC policies, metrics and trends to program staff
    • Assisting the QA Manager in conducting QA/QC training of program staff and maintaining training records
    • Assisting the QA Manager, QA team, and T-Cell manufacturing team with external audits and associated written reports
    • Assisting the QA Manager during investigations associated with QC assay failures, identifying root causes, summarizing findings and following up with corrective/preventative actions.
    • Performing other related duties as assigned

 

Qualifications

Education, Training and Experience

  • A Bachelor's degree from a recognized university in Biology, Chemistry, Molecular Biology or a related discipline
  • Four (4) years of recent experience applying QA/QC in an academic, biotechnology or pharmaceutical GMP manufacturing/laboratory environment
  • Prior hands-on experience with equipment qualification, QC test methods and other processes related to GMP/GLP practices
  • Hands-on experience with cell culturing techniques would be an asset
  • 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

 

 

To Apply

Please send your resume with cover letter to

We request that you specify the position you are applying for by identifying the Job Code only (e.g. "QCS 11-14-2018") in the subject line of your emailed application.