Provide medical laboratory leadership, discipline-specific technical expertise and quality management consultation to Operations. Ensure processes and procedures remain current and compliant with scientific advancements, technical developments and regulatory requirements in our Hematology and Chemistry departments.
This is a full time temporary role for 24 months. Health Benefits will be applicable.
- Provide troubleshooting, technical and quality assurance/quality systems support for methodologies, equipment and supplies currently in use
- Ensure policies, processes, procedures and forms remain current with applicable regulations, legislation and best practice
- Prepare and implement evaluation and validation protocols for new technologies, equipment, software, supplies and procedures
- Lead in-function projects and act as subject matter expert for cross-function projects
- Participate in the development of indicators, performance of audits, review of QA and QI activities and the evaluation of non-conformances , including development of reports and action plans
- Review and evaluate data from discipline specific QC and proficiency surveys
- Liaise with external stakeholders
- Provide support to Medical/Scientific, Supply Chain Management, Business Development, IT and other support departments as required
Minimum Qualification and Skills
- College Diploma in Medical Laboratory Technology or equivalent education and experience
- Current registration with College of Medical Laboratory Technologists of Ontario (CMLTO)
- Minimum 3-5 years previous laboratory experience in Chemistry and Hematology
- Strong Technical and Quality Systems knowledge and understanding, to provide discipline specific, expert technical and scientific support to all customers, internal and external
- Proven ability to facilitate the processes used to design, develop, validate, implement, monitor, control and continuously improve, a Quality Management System within a regulated environment.
- A clear understanding of regulatory enforcement procedures and the business impact of failing to meet external regulatory requirements.
- Facilitation skills necessary to lead discipline specific teams, and the confidence to conduct audits, issue non-conformance reports requiring corrective actions and follow-up on continued non-compliance
- The ability to use sound risk management analysis to assess the regulatory and business impact of prioritizing goals
- Excellent verbal communication skills to effectively communicate decisions and seek input
- Excellent technical writing skills to create and maintain documentation
- Strong organizational, change and project management skills to ensure that deliverables are achieved on schedule in a controlled manner