Quality and Systems Specialist Job Summary:

In accordance with the Mission, Vision and Values, and 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 and Systems Specialist is responsible for the maintenance and administration of the BC Cancer Functional Imaging Department’s Laboratory Information Management System (LIMS). This electronic system supports the manufacture, testing, and development of Good Manufacturing Practice (GMP)-compliant radiopharmaceuticals. Reporting to the departmental Quality Assurance Manager, they will also assist with the coordination and administration of the Department’s Quality Management System (QMS).

Duties/Accountabilities:

1. Maintain all aspects of the LIMS, including system and user administration, creation and amendment of electronic product methods, inventory and instrument management, equipment communication interfaces, and training.
2. Act as the LIMS point of contact with external stakeholders such as the LIMS vendor and IT services to arrange periodic system updates, user training, computer hardware requirements, as well as database server, connection, and other troubleshooting issues as necessary.
3. Arrange periodic system updates, user training, computer hardware requirements, as well as database server, connection, and other troubleshooting issues as necessary.
4. Develop and execute validation protocols to ensure regulatory compliance for electronic systems and equipment.
5. Conduct root-cause investigations associated with deviations, non-conformances, and failures through interviews, process review and root cause analysis, summarize findings, and recommend follow-up and/or corrective action.
6. Prepare and update Standard Operating Procedures and Test Methods.
7. Other activities may include assistance with the administration of the document control system, data analysis for quality trending purposes, maintenance of supplier files, among others.
8. Participate in internal audits of the laboratory’s Quality Management System.
9. Other activities may include assistance with the administration of the document control system, data analysis for quality trending purposes, review of executed batch records, among others.

Qualifications:

Education, Training and Experience
A level of education, training, and experience equivalent to a Bachelor’s in Science, Computer Science, Engineering, or other related discipline and three to five (3-5) years of experience in the pharmaceutical or medical device industries.
Skills and Abilities
• Demonstrated ability to operate an electronic QMS or LIMS
• Demonstrated ability to learn new techniques and apply them to everyday practice
• Knowledge of data integrity related to Good Manufacturing or Good Laboratory Practices
• Ability to efficiently manage time and organize work
• Demonstrated technical writing ability and strong attention to detail
• Ability to interact constructively and efficiently in a cross functional team environment.
• Demonstrated ability to independently manage workload priorities