Medical Technologist, Quality Specialist, Regulatory Affairs Specialist
4 Year Degree
**The ideal candidate will be MT or CLS ASCP certified. The candidate will also have extensive experience with Blood Bank FDA quality & regulatory management**
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.
Develops, implements, and maintains the Quality Management Plan, Quality Assurance Manual, and Performance Improvement Plan for the sections.
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 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.
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).
The University of Texas MD Anderson Cancer Center in Houston is one of the world's most respected centers focused on cancer patient care, research, education and prevention. It was named the nation's No. 1 hospital for cancer care in U.S. News & World Report’s rankings.It is one of only 45 comprehensive cancer centers designated by the National Cancer Institute. Since 1944, more than 1 million pat...ients have sought out MD Anderson’s expertise.The institution pioneered a multidisciplinary approach to research-driven care. In Fiscal Year 2015, MD Anderson invested more than $780.5 million in research