Kaiser Permanente

Laboratory Specialist V, Quality and Compliance

Kaiser Permanente$123K — $160K *
Healthcare
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • 3+ years in quality control, quality assurance, and clinical laboratory regulatory compliance.
  • 3+ years in a leadership role in a healthcare-related field.
  • Bachelor's degree in medical lab science or equivalent area, OR 7+ years of related experience, OR 10+ years of experience in medical technology or clinical laboratory sciences.
  • Clinical Laboratory Specialist License (Hawaii) or Medical Technologist License (Hawaii) required at hire.
  • Certification as a Medical Technologist, Medical Laboratory Scientist, or Clinical Laboratory Scientist preferred.Quality and process improvement certification (e.g., Lean, Six Sigma) preferred.

Responsibilities

  • Promote learning and relationship-building among cross-functional stakeholders.
  • Conduct and oversee business projects applying expertise to ensure policy adherence.
  • Develop and maintain testing and training standards and materials.
  • Guide policy development ensuring compliance with regulations and accreditation.
  • Link medical laboratory services with other departments through networking and collaboration.
  • Maintain laboratory operations aiming for efficiency and quality across services.
  • Lead service quality initiatives by managing audits and process improvements.

Benefits

  • Flexible worker location with full-time and standard work options.
  • Supportive work environment promoting teamwork and self-leadership.
  • Development opportunities for personal and professional growth through training.
  • Engagement in projects tied to strategic and business goals.
  • Policies ensuring adherence to regulatory and compliance standards.
Full Job Description
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; 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 Laboratory Specialist License (Hawaii) required at hire OR Medical Technologist License (Hawaii) required at hire
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).


Primary Location: Hawaii,Honolulu,Malama Ohana SNF/Lab
Scheduled Weekly Hours: 40
Shift: Day
Workdays: Sun, Mon, Tue, Wed, Thu, Fri, Sat
Working Hours Start: 08:00 AM
Working Hours End: 05:00 PM
Job Schedule: Full-time
Job Type: Standard
Employee Status: Regular
Worker Location: Flexible
Employee Group/Union Affiliation: NUE-HI-01|NUE|Non Union Employee
Job Level: Individual Contributor
Department: Moanalua Medical Center - Rgnl Othr-Laboratory Admin - 1208
Pay Range: $123900 - $160270 / year Kaiser Permanente strives to offer a market competitive total rewards package and is committed to pay equity and transparency. The posted pay range is based on possible base salaries for the role and does not reflect the full value of our total rewards package. Actual base pay determined at offer will be based on labor market data, internal alignment, and a candidate's years of relevant work experience, education, certifications, skills, and geographic location.
Travel: No

About Kaiser Permanente

Kaiser Permanente is a healthcare organization that provides health insurance and medical care to members in several states across the United States. The organization was founded in 1945 and is headquartered in Oakland, California. Kaiser Permanente operates hospitals, medical centers, and clinics, and offers a range of services including primary care, specialty care, and emergency care. The organization is known for its integrated healthcare model, which combines health insurance and medical care in a single system. Kaiser Permanente is also committed to promoting health equity and addressing social determinants of health, such as housing and food insecurity.
Learn more about Kaiser Permanente
Size
217,000 employees
Industry
Founded
1945

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