Molecular Diagnostic Technical Quality Specialist
At LifeLabs, we are focused on our vision of building a healthier Canada! We are the largest community diagnostics laboratory in Canada with over 350 collection centres, 16 laboratories and service over 20 million patients each year. Caring, Agile, Customer Driven, One Team - We live our values every day in what we do to help our patients and healthcare providers. With over 5,700 employees, we all make a difference and that’s why our people are so important to us. This is an exciting time to join our LifeLabs team, grow your career with us and support numerous business initiatives, innovations, best practice, and business development opportunities.
The Molecular Diagnostic Technical Quality Specialist will provide medical laboratory leadership, Molecular technical expertise and quality management consultation to Operations. Ensure processes and procedures remain current and compliant with scientific advancements, technical developments and regulatory requirements related to Molecular Diagnostics for Infectious Diseases and Clinical Microbiology.
In addition, the Molecular Diagnostic Technical Quality Specialist will support the Quality and Regulatory Affairs department with General Laboratory process and procedures as required.
This is a full-time permanent role located at 100 International Boulevard, Toronto, Ontario with occasional travel to our other laboratory sites in Ontario and British Columbia.
•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, Procurement, Business Development, IT ,and other support departments as required
•Current registration with College of Medical Laboratory Technologists of Ontario (CMLTO).
•College Diploma in Medical Laboratory Technology or equivalent education and experience.
•Minimum 5 years of current clinical Molecular Diagnostic laboratory experience.
•Preference will be given to candidates with knowledge and experience in development of molecular assays for Infectious Diseases and Clinical Microbiology.
•Experience in Clinical Chemistry, Haematology, Microbiology, Histology, and/or Cytology an asset.
•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