QUALITY & REGULATORY MANAGEMENT COORDINATOR - MOLECULAR DIAGNOSTIC

MD Anderson Cancer Center - Houston, TX

Full-time
To provide optimal patient care, Molecular Diagnostic Laboratory (MDL) offers a wide variety of state-of-the-art molecular assays for cancer diagnosis and disease monitoring. Although our primary focus has been on various leukemia/lymphoma characteristic chromosomal translocations, gene rearrangements and chimerism analysis of post allogeneic blood/marrow transplantation, the scope is also expanding to oncogene mutations, microsatellite instability and loss of heterozygosity in solid tumors. Taking advantage of automated, high-throughput, fluorescence-based assays, our lab is able to accommodate a large volume of test requests and generate highly reproducible results within a rapid turn around time. To facilitate the transfer of new technology to clinical practice, we devote a team of highly motivated medical technologists to research development with the goal of taking the lead in the field of molecular diagnosis.

Monitors/Maintains Regulatory Compliance

  • Obtains and communicates current information regarding regulatory requirements while demonstrating job knowledge and proficiency to monitor evaluate and improve the quality efficiency and appropriateness of section testing, processes for all main campus Labs as well as HAL's.
  • 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.
Manages Quality Systems
  • Manages Multiple Quality Systems: Document Control, Procedure Development, Change Control, Deviation Management, Systems Validation, and Corrective and Preventive Actions, Donor Notifications, and Recalls.
Facilitates Quality Improvement
  • Performs Quality Audits. Reviews deviations, problems and data to identify opportunities for improvement. Plans and implements quality improvement projects based on reviews. Reports and/or reviews all change control submissions, CAP proficiencies, deviations, FDA reportable errors, complaints, and adverse reactions. Assists with identifying and developing appropriate indicators, as well as collecting data for quality improvement indicators and projects for all laboratory sections including HAL's.
Other duties as assigned

Bachelor's degree. Five years of professional experience, to include three years of the following: policy development, quality assurance, regulatory compliance, strategic planning or directly related healthcare experience. With preferred degree, three years of experience is required. Certified Medical Technologist (MT) by the American Society of Clinical Pathologist Board of Registry (BOR) or Certified Clinical Laboratory Scientist (CLS) by the American Society of Clinical Pathologist Board of Registry (BOR). It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html
Additional Information
Requisition ID: 124811
Employment Status: Full-Time
Employee Status: Regular
FLSA: exempt and not eligible for overtime pay
Work Week: Days, Rotating, Weekends
Fund Type: Hard
Pivotal Position: Yes
Minimum Salary: US Dollar (USD) 68,800
Midpoint Salary: US Dollar (USD) 86,000
Maximum Salary : US Dollar (USD) 103,200