Technical Quality Specialist - Pre-Analytical - Part Time Job

Provide medical laboratory leadership, discipline-specific technical expertise and quality management consultation to Operations. Ensure processes and procedures remain current and compliant with technical developments, regulatory requirements, scientific advancements and patient safety initiatives in all pre analytical and post analytical (pre and post examination) processes; Patient Service Centres, Mobile Collections, Specimen Management departments and the Customer Care Centre.

This is a part time temporary position for 24months.

Core Accountabilities

• Provide technical, quality assurance/quality systems and troubleshooting support for methodologies, equipment and supplies currently in use
• Ensure pre and post analytical policies, processes, procedures, job aids and forms remain current with applicable regulations, legislation and best practice
• Prepare and implement instructions and evaluation protocols for new tests, equipment, software, supplies and procedures
• Mentors individuals to perform such tasks as designing and performing evaluations, writing procedures, competency testing, internal audits, troubleshooting, statistical analysis, etc.
• 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 design of reports and action plans
• Ensures that LifeLabs complies with both internal and external quality standards as defined by Medical Scientific staff, Diagnostic Accreditation Assessment Program DAP and ISO 15189.
• Consult on complaints and non-conformances providing audit trail as required
• In alignment with the Medical/Scientific team, ensure patient safety initiatives are effectively designed and implemented in all processes
• Provide support to Medical/Scientific, Supply Chain Management, Business Development, Specialty Services, IT, Operations Support, Education and Training, Billing and other support departments as required
• Observes and executes all safety and security policies and regulations
• Other duties as required

Minimum Qualifications and Skills

• Degree or Diploma in Medical Laboratory Technology or equivalent education and experience
• Registration the Canadian Society of Medical Laboratory Science (or eligibility for CSMLS)
• Minimum 3-5 years previous discipline-specific laboratory experience
• Strong Technical and Quality Systems knowledge and understanding, to provide expert technical 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