Laboratory Specialist V, Quality, Compliance, Research & Development
Laboratory Specialist V, Quality, Compliance, Research & Development
Job Description
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; 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 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.
- Leads service quality by: implementing applicable policies and procedures for audit and process improvement projects; guiding internal audit processes to verify quality of technical and/or non-technical processes; mitigating deviations from expected quality control results; proactively monitoring that tests are performed properly and results are verified before being shared; evaluating specimens and guiding others through the collection and processing of specimens according to established time and quality standards; reviewing proficiency testing performance reports and identifying proficiency testing concerns; and applying strategies to resolve complex pre-analytical workflow concerns/problems.
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.
- Bachelors 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.
- Clinical Microbiologist Scientist License (California) required at hire OR Clinical Reproductive Biologist Scientist License (California) required at hire OR Clinical Genetic Molecular Biologist Scientist License (California) required at hire OR Clinical Toxicologist Scientist License (California) required at hire OR Clinical Chemist Scientist License (California) required at hire OR Clinical Hematologist Scientist License (California) required at hire OR Clinical Laboratory Scientist License (California) required at hire OR Clinical Cytogeneticist License (California) required at hire OR Clinical Immunohematologist License (California) required at hire OR Clinical Histocompatibility Scientist License (California) required at hire
- Knowledge, Skills, and Abilities (KSAs): Computer Literacy; Member Service; Medical Sanitation and Infection Control; Medical Terminology; Medical Equipment; Patient Sample Collection; Business Process Improvement; Cost Optimization; Operational Excellence; Operations Management; Compliance Management; Confidentiality; Health Care Compliance; Maintain Files and Records; Employee Training; Stakeholder Management; Legal and Regulatory Requirements; Safety Management; Health Care Quality Standards; Quality Improvement; Quality Assurance and Effectiveness
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; 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 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.
- Leads service quality by: implementing applicable policies and procedures for audit and process improvement projects; guiding internal audit processes to verify quality of technical and/or non-technical processes; mitigating deviations from expected quality control results; proactively monitoring that tests are performed properly and results are verified before being shared; evaluating specimens and guiding others through the collection and processing of specimens according to established time and quality standards; reviewing proficiency testing performance reports and identifying proficiency testing concerns; and applying strategies to resolve complex pre-analytical workflow concerns/problems.
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.
- Bachelors 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.
- Clinical Microbiologist Scientist License (California) required at hire OR Clinical Reproductive Biologist Scientist License (California) required at hire OR Clinical Genetic Molecular Biologist Scientist License (California) required at hire OR Clinical Toxicologist Scientist License (California) required at hire OR Clinical Chemist Scientist License (California) required at hire OR Clinical Hematologist Scientist License (California) required at hire OR Clinical Laboratory Scientist License (California) required at hire OR Clinical Cytogeneticist License (California) required at hire OR Clinical Immunohematologist License (California) required at hire OR Clinical Histocompatibility Scientist License (California) required at hire
- Knowledge, Skills, and Abilities (KSAs): Computer Literacy; Member Service; Medical Sanitation and Infection Control; Medical Terminology; Medical Equipment; Patient Sample Collection; Business Process Improvement; Cost Optimization; Operational Excellence; Operations Management; Compliance Management; Confidentiality; Health Care Compliance; Maintain Files and Records; Employee Training; Stakeholder Management; Legal and Regulatory Requirements; Safety Management; Health Care Quality Standards; Quality Improvement; Quality Assurance and Effectiveness
About Kaiser Permanente
At Kaiser Permanente, we’re all focused on helping people and providing high-quality, affordable health care services and to improve the health of our members and the communities we serve. Across our organization, we’re fiercely committed to our members, our mission, our communities, and each other. We know that each part of the Kaiser Permanente team is essential to our success. Together, we are more than 235,000 dedicated professionals working to advance Kaiser Permanente’s commitment to delivering a healthier tomorrow.
Driven by our collective passion at Kaiser Permanente, we strive to make health care more innovative and compassionate. With the wellness of our patients and our communities at heart, we work to revolutionize health and care from more than 650 locations in 8 states and D.C.
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