Salary Range: $69,218-$99,501/year. The starting salary for this position would be determined with consideration of the successful candidate’s relevant education and experience, and would be in alignment with the provincial compensation reference plan. Salary will be prorated accordingly for part time roles.

Job Summary:

In accordance with the Mission, Vision and Values, and strategic directions of Provincial Health Services Authority patient and employee safety is a priority and a responsibility shared by everyone at PHSA, and as such, the requirement to continuously improve quality and safety is inherent in all aspects of this position.

The Research Project Coordinator in role of 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 qualification reviews, maintaining the equipment calibration/preventive program, vendor management, material, equipment, and process change risk assessments, analytical qualification reviews, quality system training, SOP and batch record review and approval, internal auditing, 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Maintaining and controlling documents and records, ensuring only current and active documents are used, and obsolete or superseded ones are archived appropriately.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.
- Process routine deviations, tracking, reviewing and approving change controls and managing the review cycles of standard operating procedures (SOPs)
- Shared responsibility for overseeing, reviewing and maintaining a comprehensive Nonconformance /Corrective and Preventive Action (CAPA) program; assisting with root-cause investigations associated with deviations and non-conformances, recommending appropriate corrective actions and ensuring timely completion, coordination and approval of nonconformance records.
- 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.
- Routine document reviews including reviews of batch production records (BPRs), assay qualifications and environmental monitoring (EM) data to support timely product clearance.
- Reviewing and approving for equipment installation qualifications, operation qualifications and performance qualifications.
- Conducts regularly internal facility audits and assisting with external FACT accreditation audit program.
- Assists in metric compilation, compiling quality metrics, key performance indicators (KPIs) trend reports and management review data for the QA Manager’s final executive review.




- 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.

Qualifications:

- A Bachelor's degree from a recognized university in Biology, Chemistry, Molecular Biology or a related discipline.
- Minimum five (5) years of experience in Quality Management Systems with particular experience in the following processes:
- vendor management,
- risk assessments, and
- non-conformance’s/corrective and preventive actions
- equipment qualifications
- analytical qualifications
- metrics compilation on key performance indicators
- software validations
- internal auditing
- 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 and pharmaceuticals 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 workplace.
- 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 electronic quality management systems (e.g. QPulse) would be an asset.
- Familiarity or experience with statistical analysis is considered an asset.

📌 Research Projects Coordinator (Victoria)
🏢 PHSA
📍 Victoria