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Quality Assurance Specialist

Job Code: QAS 05-01-2018

Reporting to the GSC Quality Systems Group Leader, the Quality Assurance Specialist implements Good Manufacturing (GMP) and Good Laboratory (GLP) practices to support the manufacture of compliant clinical trial products for the immunotherapy program, including CAR-T and TIL clinical trials at the Conconi Family Immunotherapy Laboratory in Victoria, BC. In addition they will be accountable for assuring compliance with applicable regulatory requirements and internal Quality Management System (QMS) requirements, identifying/driving quality system improvement and generation of metrics to drive continuous improvement.

Key Accountabilities

  • Plans, develops, implements, evaluates and maintains the Quality Management Program, including policies, processes and procedures in cooperation with the Quality Systems Leader for the CFIL’s GMP compliant manufacturing operations that support the CAR-T and TIL immunotherapy clinical trials. 
  • Assesses the effectiveness and identifies key opportunities for improvement in accordance with GMP and other applicable quality/regulatory standards and guidelines.
  • Ensures that the manufacturing and clean room facilities are operating in compliance with current GMP and Health Canada requirements.
  • Reviews and edits validation protocols to ensure alignment with GMP practices in order to ensure regular compliance for equipment, analytics methods, and production process in support of manufacturing operations.   
  • Coordinates and manages inspections and assessments for accreditation and/or certification by Health Canada and/or other regulatory bodies as required.
  • Maintains a comprehensive change control and validation program for changes in pipelines, processes, equipment, reagents and consumables in order to meet accreditation regulatory requirements.
  • Participates in equipment acquisition and qualification, and ensures equipment calibration, routine maintenance and testing activities are performed on schedule.
  • Manages and controls documents and records, ensuring only current and valid documents are used, and obsolete or superseded ones are archived appropriately. 
  • Prepares quality reports for annual review of the QMS. Ensures that the performance of the QMS is periodically reviewed by senior management for effectiveness, continuing suitability and identifying areas needing improvement.
  • Provides leadership to other Quality Assurance staff, including coaching, mentoring, direct supervision, as assigned.
  • Maintains a comprehensive internal and supplier audit program, generates audit schedules and conducts audits as needed.
  • Assists with the development of an appropriate quality control program to ensure conformity of raw material, purchased reagents and material, and final products to quality standards.
  • Conducts root-cause investigations associated with deviations, non-conformances, and failures through interviews, process review and root cause analysis, summarizes findings, and recommends follow-up and or/corrective actions.
  • Identifies quality training needs and assists in developing and conducting training sessions for manufacturing and research staff. 
  • Supports the preparation of regulatory submissions as required through the gathering of data and information, completing forms, reviewing and providing guidance to those writing submissions.      

 

Qualifications

A level of education, training, and experience equivalent to a Bachelor of Science Degree in Biology, Engineering or other related discipline and three to five years of direct QA/QC experience in the pharmaceutical/biotech environment. Must have at least 3 years experience in Quality Assurance supporting drug/biologics/cell therapy manufacturing for clinical and/or commercial use.

Demonstrable working knowledge and technical understanding of Canadian and international (e.g. ICH) cGMP regulations, procedures and guidelines that govern manufacturing, quality control and quality assurance of biologics/cell therapy/drugs produced for clinical trial investigation. Expert knowledge of cGMP principles with respect to FDA and Health Canada regulations.

Prior hands on experience with equipment qualification, test methods and other processes related to GMP/GLP practices. High attention to detail, excellent organizational and time management skills and clear, concise writing and proof-reading skills. Ability to interact constructively and efficiently in a cross functional team environment. Capacity to independently manage multiple priorities in a fast-pace manufacturing environment. Skilled use of Word, Excel and other similar programs along with experience with an electronic Quality Management System or Laboratory management System is an asset. Knowledge of clinical trials in Canada, cell therapy, genomics, immunology and/or immunotherapy would be considered a plus.

 

 

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. "QAS 05-01-2018") in the subject line of your emailed application.