Clinical Laboratory Quality Assurance Manager

1 week ago

Jupiter, Florida, United States Access Medical Laboratories Full time
Job Title: Clinical Laboratory Quality Assurance Manager

Access Medical Laboratories is seeking a highly skilled Clinical Laboratory Quality Assurance Manager to oversee and enhance the overall quality management within our clinical laboratory. This role ensures that all laboratory processes comply with regulatory requirements, industry standards, and best practices to provide accurate and reliable test results.

Key Responsibilities:
  • Quality Management: Develop, implement, and maintain the laboratory's QA in accordance with applicable regulatory requirements (e.g., CLIA, CAP, ISO 15189).
  • Laboratory Processes: Lead, organize, and maintain all department and laboratory processes, procedures, and administrative duties.
  • Collaboration and Communication: Act as liaison with external parties on matters relating to QC testing status, approvals, rejections, documentation status, and any other QC matters to support all internal departments and customers.
  • Continuous Improvement: Collaborate with laboratory staff and other stakeholders to identify opportunities for improvement and implement best practices.
  • Instrumentation and Equipment: Facilitate the evaluation of new testing applications and instrumentation. Assist in the purchase and commission of analytical and instrumentation. Ensure there are efficient instruments for the workload of samples.
  • Problem-Solving: Provide guidance to resolve problems with instruments, test methods, lab reagents, standards, and samples.
  • Performance Monitoring: Monitor key performance indicators (KPIs) to assess laboratory performance and identify areas for improvement.
  • Training and Development: Develop and deliver training programs to laboratory staff on quality management principles, regulatory requirements, and best practices.
  • Risk Management: Identify potential risks to the quality and reliability of laboratory services and implement strategies to mitigate these risks.
  • Reporting and Compliance: Prepare and present quality reports to senior management and regulatory authorities as required.
Requirements:
  • Bachelor's degree in Medical Technology, Clinical Laboratory Science, or a related field.
  • 5+ years of QA lab experience in the laboratory setting required.
  • Registered Medical Technologist, ASCP, AMT, or NCA and must qualify as Testing Personnel under CLIA guidelines.
  • Valid Florida Clinical Laboratory Supervisor's license required.
  • Certification in Quality Management (e.g., ASQ CQE, CQA) or related certification is highly desirable.
  • In-depth knowledge of laboratory regulatory requirements and standards (e.g., CLIA, CAP, ISO 15189).
  • Strong understanding of quality management principles, methodologies, and tools.
  • Excellent analytical, problem-solving, and decision-making skills.
  • Demonstrated leadership and organization skills.
  • Excellent oral and technical writing skills with the ability to interface effectively and professionally at all levels.

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