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Kaiser Permanente · 1 month ago

Laboratory Specialist V, Quality, Compliance, Research & Development

Berkeley, CA

Full-time

Onsite

Senior Level

7+ years exp

Kaiser Permanente is a healthcare organization focused on quality and compliance in laboratory services. They are seeking a Laboratory Specialist V to develop and implement quality assurance plans, ensure compliance with regulations, and monitor laboratory operations to improve service quality and efficiency.

Health CareHospitalMental HealthNon ProfitPersonal Health

Comp. & Benefits

H1B Sponsor Likely

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

Qualification

Quality AssuranceRegulatory ComplianceClinical Laboratory SciencesLeadership ExperienceMedical Laboratory ScienceQuality ImprovementProcess ImprovementTraining DevelopmentComputer LiteracyStakeholder ManagementMedical TerminologyCost OptimizationOperational ExcellenceHealth Care ComplianceEmployee TrainingSafety Management

Required

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

Preferred

Medical Technologist OR Medical Laboratory Scientist OR Clinical Laboratory Scientist Certification

Quality and process improvement certification (e.g., Lean, Six Sigma, Total Quality Management)

Company

Kaiser Permanente

Glassdoor3.9

Kaiser Permanente is a health organization that offers disease prevention, mental healthcare, and chronic disease management services.

Founded in 1945

Oakland, California, USA

10001+ employees

https://healthy.kaiserpermanente.org

H1B Sponsorship

Kaiser Permanente has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2025 (3)

2024 (1)