Laboratory Specialist V, Quality and Compliance

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