Laboratory Specialist 6 - 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.

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.

• Minimum five (5) years of experience in quality control, quality assurance, and clinical laboratory regulatory compliance.
• Minimum five (5) 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 ten (10) years of experience in medical technology, clinical laboratory sciences, or health care related field OR Minimum thirteen (13) years of experience in medical technology, clinical laboratory sciences, or health care related field.

• Clinical Cytogeneticist License (California) required at hire OR Clinical Immunohematologist License (California) required at hire OR Clinical Laboratory Scientist License (California) required at hire OR Clinical Microbiologist Scientist License (California) required at hire OR Clinical Genetic Molecular Biologist Scientist License (California) required at hire OR Clinical Histocompatibility Scientist License (California) required at hire OR Clinical Chemist Scientist License (California) required at hire OR Clinical Toxicologist Scientist License (California) required at hire OR Clinical Hematologist Scientist License (California) required at hire OR Clinical Reproductive Biologist Scientist License (California) required at hire

• Minimum five (5) years of experience in quality control, quality assurance, and clinical laboratory regulatory compliance.
• Minimum five (5) 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 ten (10) years of experience in medical technology, clinical laboratory sciences, or health care related field OR Minimum thirteen (13) years of experience in medical technology, clinical laboratory sciences, or health care related field.

• Clinical Cytogeneticist License (California) required at hire OR Clinical Immunohematologist License (California) required at hire OR Clinical Laboratory Scientist License (California) required at hire OR Clinical Microbiologist Scientist License (California) required at hire OR Clinical Genetic Molecular Biologist Scientist License (California) required at hire OR Clinical Histocompatibility Scientist License (California) required at hire OR Clinical Chemist Scientist License (California) required at hire OR Clinical Toxicologist Scientist License (California) required at hire OR Clinical Hematologist Scientist License (California) required at hire OR Clinical Reproductive Biologist Scientist License (California) required at hire

• Medical Technologist OR Medical Laboratory Scientist OR Clinical Laboratory Scientist Certification.
• Quality and process improvement certification (e.g., Lean, Six Sigma, Total Quality Management).

• Medical Technologist OR Medical Laboratory Scientist OR Clinical Laboratory Scientist Certification.
• Quality and process improvement certification (e.g., Lean, Six Sigma, Total Quality Management).

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