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.

Reporting to the Manager, Quality, Safety and Performance Improvement, the Senior Quality Assurance Coordinator, implements quality and improvement programs for organ donation and transplantation. In addition, they will assist in the coordination and administration of the Quality Management System for compliance to Health Canada Regulations, CSA Z900 standards, Accreditation Canada, and the clinical post-transplant follow-up of patients.

Duties/Accountabilities:

• Coordinates and maintains the Quality Management Program, including policies, processes and procedures under the direction of the QA Manager for BCT’s Provincial Organ Donation and Transplantation mandate.

• Reviews, edits and maintains quality protocols, records and reports to ensure alignment with PHSA, BCT and Health Canada practices in order to ensure compliance and meeting quality goals.

• Fully responsible for a comprehensive organ chart audit program ensuring chart accuracy and completion, assignment of charts and resolution of technical chart issues. Presents findings from chart audit trends to Quality team and other clinical leaders.

• Ensures continued direct patient care through detailed review and timely communication of donor lab results to transplant programs, physicians, Transplant Infectious Disease specialists. With medical leadership, ensures appropriate Post-transplant follow-up of patients.

• Coordinates quality committee meetings, and reviews/prepares quality data reports to identify trends and identify system improvements.

• Maintains a comprehensive internal and supplier audit program, generates audit schedules and conducts audits as needed.

• Maintains the Equipment Management Program, and ensures equipment calibration, qualification, routine maintenance and testing activities are performed on schedule.

• Conducts root-cause investigations associated with deviations, non-conformances, PSLS, and failures through interviews, process review, summarizes findings, and recommends follow-up and/or corrective actions.

• Identifies quality training needs and assists in developing and conducting training sessions for organ donation and quality staff.

• Supports the preparation of regulatory submissions and Error/Accident/Adverse Reaction reports as required through the gathering of data and information, completing forms, reviewing and providing guidance to those writing submissions.

• Manages and controls documents and records, ensuring only current and valid documents are used, and obsolete or superseded ones are archived appropriately.

• Provides guidance to other Quality Assurance staff, including coaching, mentoring, direct supervision, as assigned.

Qualifications:

A level of education, training, and experience equivalent to a Science Degree in Biology/ Microbiology, or other related discipline and three to five years of direct QA/QC experience in a healthcare/biotech/laboratory environment.

Demonstrated experience in conducting internal audits, record reviews, managing a controlled documentation system preferred. 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 manage multiple priorities in a regulated environment independently. 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 the requirements of the Canadian Standards Association and Health Canada relating to cells, tissues and organs, and familiarity with standards of practice such as ISO, GMP/GLP, Accreditation Canada, and/ or National Quality Institute criteria considered an asset.