Laboratory Specialist V, Quality and Compliance

Job Summary

In addition to the responsibilities listed below, this position is also responsible for collaborating on the development and implementation of comprehensive laboratory quality assurance (QA) plans; working with technical and clinical staff to implement and execute attainable and measurable regional standards for laboratory quality of service; monitoring progress on short and long-term quality assurance goals and objectives consistent with strategic and business plans; investigating and resolving highly complex or unusual laboratory problems; partnering with technical supervisors to perform regular inspections of assigned laboratory locations within the region to monitor compliance with regulatory requirements, QA systems, testing procedures, personnel, physical plant, and equipment; ensuring laboratory QA system complies with current regulations and legislation, identifying trends and collaborating with lab personnel to drive appropriate action plans and responses to these issues; monitoring, maintaining, and training users on quality systems; writing and developing quality administrative policies in collaboration with other internal teams; conducting audit surveys to ensure compliance with regulatory requirements; working with departments to coordinate selection, ordering, submissions, and responses for proficiency testing surveys; role modeling the use of total quality management tools and techniques to improve lab operations; driving initial testing and setup procedures (e.g., verification, assay development, calibration, sensitivity studies) for new or replaced instruments; and leading the creation and implementation of validation plans.

Essential Responsibilities

• Promotes learning in others by communicating information and providing advice to drive projects forward;
• Buils relationships with cross-functional stakeholders;
• Listens, responds to, seeks, and addresses performance feedback;
• Provides actionable feedback to others, including upward feedback to leadership and mentors junior team members;
• Practices self-leadership; creates and executes plans to capitalize on strengths and improve opportunity areas; influences team members within assigned team or unit;
• Adapts to competing demands and new responsibilities; adapts to and learns from change, challenges, and feedback;
• Models team collaboration within and across teams;
• Counsels others to apply local and national standards, regulations, technology, and initiatives;
• Serves as a link between medical laboratory services and other services by: routinely attending meetings and seminars to keep informed of regulatory/accreditation changes and issues, inspection citations, current events, and trends relevant to services, quality, and training;
• Maintains medical laboratory operations and improves processes by: ensuring efficient operations, quality, service, patient safety, member/customer satisfaction, and cost effectiveness through evaluation and standardization of technical and/or non-technical services and processes; facilitating work plan processes to improve systems across the continuum of care; preparing for the implementation of new testing methodologies, processes, and technology that have the potential to improve service, quality, and/or efficiency; resolving complex laboratory and patient/member problems; mentoring more junior staff to ensure teamwork and a progressive work environment; monitoring and driving day-to-day technical and/or non-technical laboratory operations; developing inventory and maintenance systems, assessing supplies inventory, and evaluating usage and costs to plan for potential future issues; and guiding ongoing technical and/or non-technical project management, including local, regional, and national initiatives, and status reports.

Minimum Qualifications

• Minimum three (3) years of experience in quality control, quality assurance, and clinical laboratory regulatory compliance;
• Minimum three (3) years of experience in a leadership role with or without direct reports in a healthcare related field;
• Bachelor's degree in medical lab science or equivalent, or health care related field AND minimum seven (7) years of experience in medical technology, clinical laboratory sciences, or health care related field OR Minimum ten (10) years of experience in medical technology, clinical laboratory sciences, or health care related field.

Preferred Qualifications

• Medical Technologist OR Medical Laboratory Scientist OR Clinical Laboratory Scientist Certification;
• Quality and process improvement certification (e.g., Lean, Six Sigma, Total Quality Management).