QUALITY CONTROL MANAGER-HSOM TRANSPLANT

University of Alabama at Birmingham

The Department of Surgery/Transplantation will have this position serve as the Safety Officer and manage the STC Extra Vessel program for the UAB Transplant Center.

General Responsibilities

• To manage the Southern Tissue Center (STC) quality control program.

• To ensure the tissue centers' compliance with FDA regulations under 21 CFR, part 1270 and 1271 Food and Drug Administration Final Rule: Human Tissue Intended for Transplantation.

• To review all activities performed by the Sterile Materials Management officer.

• To prepare and process islets for transplantation.

• To handle all aspects of tissue banking.

• To assist and serve as backup of STC Director of Operations as needed.

Key Roles & Responsibilities

• Manages the quality control aspects of the STC to ensure FDA compliance.

• Reviews all tissue bank donor charts.

• Conducts audits.

• Handles raw material receiving and conducts environmental monitoring of the clean rooms. Maintains the facility to ensure the safety of employees and maintenance of the Good Manufacturing Practices (GMP) clean rooms.

• Ensures regulatory compliance with all applicable agencies.

• Develops and prepares quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, etc.

• Monitors standards for quality as well as health and safety, defining quality procedures in conjunction with operations manager and staff.

• Serves as Islet Isolation processor.

• Prepares and processes patient pancreas for auto islet transplantation.

• Trains new staff.

• Reviews Islet processing charts and transports pancreas/islets to UAB Hospital.

• Serves as tissue bank processor.

• Manages all aspects of tissue banking under American Association of Tissue Banks (AATB) standards. Prepares and processes autologous skull caps for storage for UAB and Children's Hospital of Alabama.

• Reviews charts and provides environmental monitoring and cleaning.

• Reviews charts and identifies new areas of education.

• Trains and handles on-boarding of new STC staff on quality standards.

• Serves as backup to the operations manager, as needed.

• Performs other duties as assigned.

Knowledge, Skills, Abilities & Work Characteristics

Prior experience in the handling human tissue that is used in transplantations, including an overall in depth understanding of government requirements, regulations, reporting, and standards in this area.

Salary Range: $50,050 - $81,330

Education

• Bachelor's degree in a related field and five (5) years of related experience required.

• Work experience may NOT substitute for education requirement.

Licenses

Currently certified as a Certified Tissue Bank Specialist (CTBS) from the American Association of Tissue Banks (AATB), or CTSB license is acquired within 6 months to 1 year of employment.

UAB is an Equal Employment/Equal Educational Opportunity Institution dedicated to providing equal opportunities and equal access to all individuals regardless of race, color, religion, ethnic or national origin, sex (including pregnancy), genetic information, age, disability, and veteran's status. As required by Title IX, UAB prohibits sex discrimination in any education program or activity that it operates. Individuals may report concerns or questions to UAB's Assistant Vice President and Senior Title IX Coordinator. The Title IX notice of nondiscrimination is located at uab.edu/titleix.