QUALITY CONTROL MANAGER-HSOM TRANSPLANT

The University of Alabama at Birmingham

This position will manage the Southern Tissue Center (STC) quality control program. Will 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 and review all activities performed by the Sterile Materials Management officer.

Key Duties, Primary 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.
• Reviews Islet processing charts and transports pancreas/islets to UAB Hospital.
• Will also train new staff.
• 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.
• Perform other duties as assigned

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.
• Currently certified as a Certified Tissue Bank Specialist (CTBS) from the American Association of Tissue Banks (AATB) required.