The Compensation Range is the span between the minimum and maximum base salary for a position. The midpoint of the range is approximately halfway between the minimum and the maximum and represents an employee that possesses full job knowledge, qualifications and experience for the position. In the normal course, employees will be hired, transferred or promoted between the minimum and midpoint of the salary range for a job.
Note: Applications will be accepted until 11:59 PM on the day prior to the Posting End Date above.
Job End Date
May 31, 2025This position is located within a health-care facility, therefore, the successful candidate will be required to provide verification of full vaccination against Covid-19 provided prior to the start date, as required by a provincial health mandate.
At UBC, we believe that attracting and sustaining a diverse workforce is key to the successful pursuit of excellence in research, innovation, and learning for all faculty, staff and students. Our commitment to employment equity helps achieve inclusion and fairness, brings rich diversity to UBC as a workplace, and creates the necessary conditions for a rewarding career.
Job Summary
The University of British Columbia (UBC) - Centre for Cardiovascular Innovation (CCI) is a clinical research operational center providing services to cardiovascular investigators working in British Columbia (B.C.) to facilitate national and international clinical trials.
CCI-CIC is dedicated to improving the health of patients with cardiovascular disease. CCI-CIC provides physical and personnel infrastructure to enhance the research capacity of its member investigators.
Maintaining and building the highest standards of quality and regulatory compliance in all facets of cardiovascular research makes the role of the Quality Assurance Specialist pivotal to CCI operations.
Moreover, the role entails maintaining and improving the efficacy of the Standard Operating Procedures (SOPs) or Quality Management System (QMS) in CCI, bringing it into compliance with Canadian and international standards while promoting ongoing quality improvements
Organizational Status
The Quality Assurance Specialist is based within UBC. CCI collaborates with a comprehensive research network, promoting international and local research collaborations in cardiovascular health.
The Quality Assurance Specialist reports directly to the Director, Research Operations and is expected to work closely with other team members, including data analysts, statisticians, clinical coordinators, and researchers.
Work Performed
Technical-related
Quality Assurance:
Uphold the effectiveness and accuracy of the Quality Management System (QMS) and ensure adherence to relevant national and international standards and laws. Oversee quality-related projects that spur systemic improvements while guaranteeing that they align with CCI's overall objectives. Work closely with cross-functional teams to identify nonconformities, gaps, and inefficiencies in CCI system procedures or processes. As needed, jumpstart the required corrective or preventive activities. Oversee the training and change control procedures in conjunction with the other CCI team members who handle quality assurance to guarantee complete adherence to all applicable laws and standards. Examine, review, and approve SOPs, validation/verification/stability documents, document change orders (DCO), document change requests, and document revisions. Offer CCI team members thorough training and professional direction on QMS procedures and processes. Examine risk management documents to support risk assessment and mitigation using a methodical, risk-based approach. Ensure that CCI is always audit-ready; actively participate in quality and regulatory audits. Actively participate in Management Review sessions and other projects by providing knowledge, experience, and the required backing for raising the standard of operations.
Quality Operations:
Develop quality-related metrics for internal monitoring within CCI; create related period reports for CCI top management. In charge of promptly resolving operational nonconformances (NCs), variations (VRs), reworks (RWs), and risk assessments, with a focus on careful root cause analysis at all times. Lead the cross-functional implementation of corrections and enhancements and continuously support and promote improvements in CCI's daily operations by identifying holes in the QMS. Ensure that all incoming, in-process, and finished materials/data/documents within CCI are accurately labeled and disposed of within the operations area. Supervise the distribution of QMS documents and effectively oversee the flow of records until they are completed as needed.
Management-related
Oversees a variety of duties associated with the position. Creates plans to improve work procedures continuously. Collaborates with users and stakeholders to gather needs; devises solutions for quality-related problems. Examines and suggests strategies and techniques to raise the standard of CCI operations.
Consequence of Error/Judgement
The role involves considerable initiative and attention to detail, with the incumbent managing multiple complex projects. Errors in judgment regarding project priorities, schedules, and resource requirements can result in project delays.
Effective communication is crucial, including clear and concise writing for documentation. The position requires working effectively under pressure to meet deadlines. Confidentiality is vital due to access to sensitive data.
Supervision Received
The Quality Assurance Specialist reports to the Director, Research Operations, with work reviewed regarding specific project objectives.
Supervision Given
No formal reports, but may supervise student staff.
Minimum Qualifications
Undergraduate degree in a relevant discipline. Minimum of two years of related experience, or an equivalent combination of education and experience.
- Willingness to respect diverse perspectives, including perspectives in conflict with one's own
- Demonstrates a commitment to enhancing one's own awareness, knowledge, and skills related to equity, diversity, and inclusion
Preferred Qualifications