Job Summary:

In accordance with the Mission, Vision, Values and strategic direction of PHSA, safety, including both patient and employee safety, is a priority and a responsibility shared by everyone at PHSA. 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 Coordinator, Quality Assurance is responsible for the coordination and support of activities relating to direct clinical patient care and safety, quality assurance and management for donation and transplant programs, and ensuring compliance with Health Canada Regulations.
The Coordinator, Quality Assurance reviews and analyzes clinical data that relates to continued transplant patient care, safety, performance, critical events follow up and process redesign. The Coordinator, Quality Assurance assists in the planning, development, implementation, conducting and evaluation of diverse quality projects of varying size and scope, and ongoing related activities, in a complex and changing multidisciplinary environment.

Duties/Accountabilities:

•    Coordinates the execution of quality initiatives within the various components of donation and transplant, ensuring initiatives are completed in an efficient manner that they adhere to protocols, and conform to regulatory and quality system requirements. Includes assisting and conducting audits, following established protocols and reporting results to quality and clinical leaders.
•    Supports, identifies, collects, and analyzes, relevant information relating to quality improvement, audits, accreditation, critical events/patient safety events follow up, key performance indicators (KPIs), and other quality monitoring activities to help assess the effectiveness of BCT Quality programs.
•    Performs and maintains the quality control for clinical processing of Islet cells at the Ike Barber Human Islet Transplant Laboratory by ensuring standard operating procedures & Health Canada Regulations are being adhered to and providing training on any revised SOPs. Reviews calculations, chart documentation, equipment/supplier records, and follows up on any discrepancies.
•    Performs detailed donor and laboratory quality chart audits. Identifies trends and issues, develops training materials for staff on improving chart completion, donor suitability assessment documentation, and ensuring SOPs are being followed correctly.  
•    Communicates and collaborates with a variety of front line physicians, transplant infectious disease specialists, nurses, program managers, coordinators and donation/transplant staff regarding donor information and test results.
•    Participates in comprehensive internal and supplier audit program, quality control program, generates draft regulatory reports for submission to management.   
•    Maintains a comprehensive change control and validation program for changes in equipment, processes, materials, and documentation in order to meet regulatory/accreditation requirements. Ensures equipment calibration, routine maintenance and testing activities are performed on schedule and to specification.
•    Conducts root-cause investigations associated with deviations, PSLS, non-conformances and failures through interviews, process review, summarizes findings and prepares reports for the Senior Quality Clinical Specialist.
•    Supports the preparation of regulatory submissions as required through the gathering of data and information, completing forms, and creating clinical reports.
•    Provides assistance with quality improvement projects and ongoing activities by liaising with staff and hospital partners.

Qualifications:

A level of education, training and experience equivalent to a Bachelors degree in biology/microbiology, health sciences or Health Information and three to five years work-related experience in a healthcare/biotech/laboratory environment.
Knowledge of Health Canada / CSA standards, GxP, ISO, and/or electronic document management systems an asset.
High attention to detail, excellent organizational and time management skills and clear, concise writing and proof-reading skills. Demonstrated ability to build and maintain effective relationships and the commitment to the value of continuous learning.  Excellent communication skills, both written and verbal. Proven ability to work collaboratively and efficiently in a cross functional team environment to achieve common goals.  Knowledge in Quality Management, Performance Improvement, Safety and Accreditation standards.  Understanding of and practical skills in project coordination/management. Strong skills in relevant computer software applications including spreadsheet programs, word processing software, and internet search engines, websites and navigation. Related experience in conducting literature searches and reviews, best practice reviews, working collaboratively with a wide range of internal and external stakeholder groups.