Quality Control Supervisor

2 months ago


Vancouver, Canada BC Cancer Agency Full time

**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.

**Job Reference No. QCS_RP_R00008_Quality Systems_2023_10_19**:
**_Role Summary
-**:
In accordance with the Mission, Vision and Values, and the strategic directions of Provincial Health Services Authority, patient 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 Quality Control Supervisor will support the manufacturing, quality control and quality assurance activities for the BCCA’s Cancer Immunotherapy Program, at the BCCA's Deeley Research Centre (DRC). The Quality Control Supervisor will provide supervision of the Quality Control group, ensuring efficient, orderly and seamless operation of the quality control laboratory at the CFIL including resource scheduling. Operations 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 Supervisor receives guidance from and reports to, the BCCA Cancer Immunotherapy Program's QS 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 QS 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
- Conducts investigations regarding out of specification (OOS) results and oversees the implementation of corrective action items
- Maintains the environmental monitoring program, reviews EM results and takes appropriate actions for abnormal results
- Monitoring, trending and analyzing QC data and generating analysis reports to gather metrics for continuous improvement in areas of responsibility and for input into the Management Reviews
- Oversees analytical qualifications and re-qualifications
- Oversees assay development
- Communicating QC policies, metrics and trends to program staff
- Participates in Point of Care activities and supports sites.
- Participates in management reviews of process performance, product quality and advocating continuous improvement
- Assisting the QS Manager in conducting QA/QC training of program staff and maintaining training records
- Assisting the QS Manager, QA team, and T-Cell manufacturing team with external audits and associated written reports
- Assisting the QS 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
- Participates in the screening and interview process for new Quality Control Technician hires
- Performs annual reviews in conjunction with the Quality Manager for Quality Control staff.

**_Qualifications_**:
**Education, Training and Experience**:

- A Bachelor's degree from a recognized university in Biology, Chemistry, Molecular Biology or a related discipline
- Minimum two (2) years of experience in leadership and training of team members.
- Prior hands-on experience with equipment qualification, QC test methods a



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