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.

• Promotes learning in others by communicating information and providing advice to drive projects forward; builds 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.
• Conducts or oversees business-specific projects by applying deep expertise in subject area; promotes adherence to all procedures and policies. Partners internally and externally to make effective business decisions; determines and carries out processes and methodologies; solves complex problems; escalates high-priority issues or risks, as appropriate; monitors progress and results. Develops work plans to meet business priorities and deadlines; coordinates and delegates resources to accomplish organizational goals.
  
  Recognizes and capitalizes on improvement opportunities; evaluates recommendations made; influences the completion of project tasks by others.
• Maintains testing and training standards by: leading the development of technical and/or non-technical training materials; evaluating relevant personnel competency on an ongoing basis; and defining training needs, coordinating regular, in-service, and competency training, and completing own training.
• Maintains compliance and accreditation by: guiding the development of policies and work instructions in alignment with applicable regulations, license requirements, accreditation standards, and inspection checklists pertaining to laboratories and facilities where testing is performed; promoting adherence to all requirements related to the recruitment, processing, testing, storage, and distribution of materials and samples; facilitating accreditation inspection processes, including communication with inspectors, lab supervisors, and managers;
  
  refining the license renewal process; and driving updates to technical and/or non-technical documentation.
• 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; capitalizing on cross-functional teams to proactively evaluate and improve technical and/or non-technical quality management systems; driving networking and collaboration across internal teams locally to coordinate and align lab operations, quality, and utilization;
  
  and coaching others to apply local and national standards, regulations, technology, and initiatives.
• 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…