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UT Health Quality Improvement Coordinator (Cellular Therapy) - Pediatric Surgery - Regenerative Medicine in Texas Medical Center-Houston, Texas

Quality Improvement Coordinator (Cellular Therapy) - Pediatric Surgery - Regenerative Medicine

Texas Medical Center-Houston, Texas

Hot

Research

McGovern Medical School at UTHealth

Requisition #: 20000114

Position Summary:

Develops and implements strategic action, quality improvement and risk management plans. Identifies potential weaknesses and provides senior management with an analysis of outcomes.

Pediatric Surgery - Regenerative Medicine (Cellular Therapy)

Full Time

Exempt

TMC Location

The QI and regulatory activities (RA) of the Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory, an 1850 square feet FDA-registered facility located on the 6th floor of the Behavioral and Biomedical Sciences Building, where tissues and organs are processed to produce cells for clinical applications in compliance with current Good Manufacturing Practice (cGMP) of the FDA. This role also coordinates QI at the Judith R. Hoffberger Cellular Therapeutics Laboratory, a 710 square feet facility located on the 6th floor of the Medical School Building which up to now has been used as a preclinical translational laboratory. Thanks to her exceptional work contribution, the Griffin facility continues to be accredited under the new Common Standards for Cellular Therapy by the Foundation for the Accreditation of Cellular Therapy (FACT) yearly, the most prestigious and rigorous authority in the field.

Position includes occasional weekend hours and on call response, which is compensated, as well as some flexibility in hours and availability.

POSITION KEY ACCOUNTABILITIES:

  1. Conducts periodic review of records to assess and ensure compliance with internal policies and procedures.

  2. Meets and collaborates with managers to develop performance improvement plans and monitors ongoing outcomes.

  3. Conducts periodic audits of processes and data to ensure compliance and assists in preparation and success of audits from regulatory governing bodies. Includes audits of Personnel and Environment monitoring.

  4. Analyzes audit reviews to identify areas needing improvement and detection of risk management issues.

  5. Develops, implements and monitors quality improvement and risk management plans.

  6. Assist in preparation for lab FACT, CAP, and CLIA accreditation and registration by working closely with accreditation counselors/coordinators to complete required documentation, and to assist in gap analysis by preparing missing documentation as identified by accreditation organization in a timely manner.

  7. Participates as an active member of the Safety Committee and addresses areas needing improvement.

  8. Contributes to the systems applications development required to collect necessary data to monitor performance improvement indicators.

  9. Analyzes data and creates necessary quality reports to identify performance improvement issues and compares outcomes to similar institutions.

  10. Prepares statistical variances and trends in graphs and charts to review with senior management.

  11. Conducts educational training for staff regarding Performance Improvement principals and processes.

  12. Performs other duties as assigned

PREFERRED CERTIFICATIONS/SKILLS:

Certified Medical Technologist (MT) by the American Society of Clinical Pathologists (ASCP)

Certification from the Association of Clinical Research Professionals (ACRP)

MINIMUM EDUCATION:

Bachelor’s degree or related experience.

MINIMUM EXPERIENCE:

Required:

Five years professional experience in a healthcare or academic setting with one year experience with research laboratory, regulatory compliance or education. May substitute required education with additional years of equivalent experience or applicable degree on one to one basis.

Preferred:

Three years’ experience in clinical processing of cellular products and two years lead/supervisor experience.

PHYSICAL REQUIREMENT

Exerts up to 20 pounds of force occasionally and/or up to 10 pounds frequently and/or a negligible amount constantly to move objects.

SECURITY SENSITIVE: This job class may contain positions that are security sensitive and the

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University of Texas Health Science Center at Houston (UTHealth)

Established in 1972 by The University of Texas System Board of Regents, The University of Texas Health Science Center at Houston (UTHealth) is Houston’s Health University and Texas’ resource for health care education, innovation, scientific discovery and excellence in patient care. The most comprehensive academic health center in the UT System and the U.S. Gulf Coast region, UTHealth is home to schools of biomedical informatics, biomedical sciences, dentistry, nursing and public health and the John P. and Kathrine G. McGovern Medical School. UTHealth includes The University of Texas Harris County Psychiatric Center, as well as the growing clinical practices UT Physicians, UT Dentists and UT Health Services. The university’s primary teaching hospitals are Memorial Hermann-Texas Medical Center, Children’s Memorial Hermann Hospital and Harris Health Lyndon B. Johnson Hospital.

UTHealth Benefits

UTHealth offers a comprehensive and competitive benefits package. For more information on our benefits programs please refer to the UTHealth Office of Benefits Website.

https://www.uth.edu/benefits/benefits-summary.htm

Equal Employment Opportunity Statement

UTHealth is committed to providing equal opportunity in all employment-related activities without regard to race, color, religion, sex, sexual orientation, national origin, age, disability, genetic information, gender identity or expression, veteran status or any other basis prohibited by law or university policy. Reasonable accommodation, based on disability or religious observances, will be considered in accordance with applicable law and UTHealth policy. The University maintains affirmative action programs with respect to women, minorities, individuals with disabilities, and eligible veterans in accordance with applicable law.

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