The Quality Assurance Manager is responsible for overseeing and enhancing the overall quality management within the 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. The Quality Manager will lead quality improvement initiatives, manage audits and inspections, and foster a culture of continuous improvement and compliance within the laboratory.
Responsibilities:
Lead, organize and maintain all department and laboratory processes, procedures and administrative duties.
Develop, implement, and maintain the laboratory's QA in accordance with applicable regulatory requirements (e.g., CLIA, CAP, ISO 15189).
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.
Collaborate with laboratory staff and other stakeholders to identify opportunities for improvement and implement best practices.
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.
Provide guidance to resolve problems with instruments, test methods, lab reagents, standards, and samples.
Monitor key performance indicators (KPIs) to assess laboratory performance and identify areas for improvement.
Develop and deliver training programs to laboratory staff on quality management principles, regulatory requirements, and best practices.
Identify potential risks to the quality and reliability of laboratory services and implement strategies to mitigate these risks.
Prepare and present quality reports to senior management and regulatory authorities as required.
Overall responsibility to manage method validations/qualifications.
Investigate deviations and write exception documents as required, utilizing problem solving tools as needed. Demonstrate familiarity with product specifications, process reference files, code of federal regulations, and State requirements.
Responsible for investigating and processing Deviations, Out of Specifications, and Out of Trend, QC events. Identify and report non-conformances/deviations/out-of-specification events.
Qualifications:
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.