Quality & Regulatory Managment Coordinator - CORE Laboratory
**The ideal candidate for this position will be ASCP certified, have at least 5 years of quality experience to include regulatory compliance, quality assurance and strategic planning. Previous CORE Laboratory experience preferred.**
The Core Laboratory provides a broad array of routine and specialized clinical laboratory testing services available 24 hours/day on peripheral and arterial blood, urine, and other body fluids for patients throughout MD Anderson Cancer Center. A comprehensive selection of routine, high-volume automated chemistry tests as well as therapeutic drug monitoring and blood gas analysis are available employing state-of-the-art instrumentation that includes analytical laboratory automation, computer-assisted specimen storage and location, and automated chemistry workstations. Hematological disorders such as leukemias and lymphomas are assessed utilizing high-volume analyzers as well as manual counting methods. After diagnosis, additional tests may be performed to assess prognosis, progression of the disease and response to treatment. Testing for Coagulation disorders that lead to bleeding or thrombosis is available for both medical and surgical patients throughout MD Anderson.
The expertise of our Core Lab Technologists along with state-of-the-art equipment allows for a comprehensive approach to the diagnosis and interpretation of disease states as detected in the various body fluid specimens analyzed and plays an integral role in meeting the mission of the Division of Pathology and Laboratory Medicine
• Develops, implements, and maintains the Quality Management Plan, Quality Assurance Manual, and Performance Improvement Plan for the sections including HAL's.
• Reviews and monitors quality control activities for the sections. Monitors preventative maintenance of equipment and instrument quality control. Responsible for the FDA, CAP, and AABB accreditation and regulatory programs for the section, including maintaining current licensure and submission of required annual FDA report.
• Adheres to regulatory, institutional, and divisional requirements and assures section remains compliant. Facilitates the preparation for regulatory agency inspections and works with section and HAL personnel on the corrective actions to meet requirements. Manages quality audits and reviews documentation of errors and accidents.
Other duties as assigned
