Laboratory Specialist VI, Quality and Compliance

In addition to the responsibilities listed below, this position is also responsible for developing and implementing comprehensive laboratory quality assurance (QA) plans; working with technical and clinical staff to establish attainable and measurable regional standards for laboratory quality of service; establishing and implementing short and long-term quality assurance goals and objectives consistent with strategic and business plans; investigating and resolving laboratory problems at all levels; partnering with technical supervisors to perform regular inspections of all 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, monitoring trends and guiding lab personnel to formulate 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; promoting and integrating total quality management tools and techniques to improve lab operations; ensuring initial testing and setup procedures (e.g., verification, assay development, calibration, sensitivity studies) for new or replaced instruments; and owning the creation and implementation of validation plans.

• Promotes learning in others by communicating information and providing advice to drive projects forward; builds collaborative, cross-functional relationships. Solicits and acts on performance feedback; provides actionable feedback to others, including upward feedback to leadership; influences, mentors, and coaches team members. Practices self-leadership; creates, evaluates, and responds to the strengths and weaknesses of self and unit or team members. Leads the adaptation to competing demands and new responsibilities; adapts to and learns from change, challenges, and feedback. Fosters open dialogue amongst team members.
• Drives the execution of multiple work streams by identifying member and operational needs; translates business strategy into actionable business requirements; develops and updates new procedures and policies. Gains cross-functional support for objectives and priorities; determines and carries out processes and methodologies; solves highly complex issues; escalates and resolves issues as appropriate; sets standards and measures progress. Develops work plans to meet business priorities and deadlines; coordinates, obtains and distributes resources. Removes obstacles that impact performance; guides performance and develops contingency plans accordingly; influences the completion of project tasks by others.
• Maintains testing and training standards by: driving the development and use of technical and/or non-technical training materials while resolving issues related to trainings and/or training resources; ensuring relevant personnel competency meets defined standards; and assessing training needs, initiating regular, in-service, and competency training, and completing own training.
• Maintains compliance and accreditation by: monitoring 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; driving adherence to all requirements related to the recruitment, processing, testing, storage, and distribution of materials and samples; evaluating the effectiveness of accreditation inspection processes, including communication with inspectors, lab supervisors, and managers; influencing the license renewal process; and delegating and coordinating the consistent updating of technical and/or non-technical documentation.
• Serves as a link between medical laboratory services and other services by: serving on committees to communicate regulatory/accreditation changes and issues, inspection citations, current events, and trends relevant to services, quality, and training; providing guidance to cross-functional teams to proactively evaluate and improve technical and/or non-technical quality management systems; leading networking and collaboration across internal teams locally to coordinate and align lab operations, quality, and utilization; and ensuring team aligns with local and national standards and regulations, and utilizes technology and initiatives.
• Maintains medical laboratory operations and improves processes by: guiding others on 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; evaluating work plan processes to improve systems across the continuum of care; promoting new testing methodologies, processes, and technology that have the potential to improve service, quality, and/or efficiency; resolving highly complex laboratory and patient/member problems; promoting teamwork and the cultivation of a progressive work environment; overseeing day-to-day technical and/or non-technical laboratory operations; refining inventory and maintenance systems, managing supplies inventory, and proactively anticipating issues related to usage and costs; and overseeing ongoing technical and/or non-technical project management, including local, regional, and national initiatives, and status reports.
• Leads service quality by: developing applicable policies and procedures for audit and process improvement projects; driving internal audit processes to verify quality of technical and/or non-technical processes; planning for deviations from expected quality control results; providing guidance to ensure that tests are performed properly and results are verified before being shared; managing the collection of specimens to ensure they are collected and processed according to established time and quality standards; analyzing proficiency testing performance reports and resolving proficiency testing concerns; and adapting strategies to resolve novel pre-analytical workflow concerns/problems.