Cell Therapy Quality Assurance Specialist IV - Cord Blood Bank

The MD Anderson Cord Blood Bank Program creates a lifesaving product from something that was once considered medical waste. Umbilical cord blood is the blood that remains in the placenta and umbilical cord after a baby is born. This blood contains stem cells, which can be used to treat patients with many life-threatening diseases, including cancer. As a public cord blood bank, collectors collect voluntary donations from mothers at several Houston-area hospitals. Collecting cord blood poses no danger to either the mother or the baby. Our inventory is available to transplant facilities worldwide for patients who require stem cell transplantation.

SUMMARY
The Quality Assurance Specialist is responsible for managing the cleanroom facility and supporting all quality assurance operations, including document control, training, competency assessments, audits, and incident reporting. This role ensures compliance with the Cord Blood Bank Quality Assurance Program and regulatory/accreditation agencies such as the FDA, FACT, and CAP.
Key responsibilities include reviewing quality documentation, coordinating internal and external audits, reviewing batch and testing records, preparing CBUs for national and international registry listing, ensuring shipment readiness, and supporting continuous quality improvement.

At MD Anderson, we offer careers built on care, growth, and balance. Our employees enjoy a benefits package designed to support every stage of life, starting on day one.

• Paid employee medical benefits (zero premium) starting on first day for employees who work 30 or more hours per week
• Group Dental, Vision, Life, AD&D and Disability coverage
• Paid time off (PTO) and Extended Illness Bank (EIB) paid leave accruals
• Paid institutional holidays, wellness leave, childcare leave, and other paid leave programs
• Tuition Assistance Program after six months of service
• Teachers Retirement System defined-benefit pension plan and two voluntary retirement plans
• Employer paid life, AD&D and an illness-related reduced salary pay program

• Extensive wellness, recognition, fitness, employee health programs and employee resource groups

   

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  Key Functions
  Environmental Monitoring & Facility Quality Compliance

• Oversee the Environmental Monitoring (EM) program, including sampling plans, routine trending, and excursion response procedures in alignment with regulatory guidelines and the CBB Quality Management Plan.
• Ensure EM is performed under static and dynamic conditions—including during product manufacturing—and that microbiological and particle data are trended and acted upon.
• Collaborate with MD Anderson’s housekeeping team to ensure appropriate cleaning standards and staff competency for classified areas.
• Oversee qualification and quality control release testing for raw materials, in process materials, components, and final products, including growth promotion testing for all microbiology and EM media.
• Manage the automated monitoring system (daily/monthly review, alarm investigations, corrective actions, annual probe calibrations, and staff training).
• Maintain aseptic processing monitoring for both facility and personnel; drive corrective and preventive actions to maintain a controlled state.
• Review performance indicator data to identify, develop, and implement process improvements; manage environmental excursion investigations and ensure timely corrective actions.
• Develop, implement, and manage training and qualification of cleanroom staff (access, gowning, hygiene, aseptic technique, cleanroom behavior, and patient safety considerations).
• Ensure compliance with Employee and Environmental Health and Safety requirements.
• Collaborate with Institutional Facilities to ensure the cleanroom meets FDA Biological Licensure requirements.
• Perform quarterly safety inspections, communicate deficiencies, and ensure follow up is completed.

Quality Program Management

• Maintain up to date knowledge of technical procedures, policies, and regulations including FDA cGTP and cGMP, FACT NetCord, and CAP standards, and educate staff accordingly.
• Assist in developing and implementing training programs; identify improvement areas.
• Monitor staff training and competency; review and audit training records.
• Oversee the Proficiency Testing Program, submit final reports, investigate failures, and implement corrective actions.
• Mentor staff on SOP review and revision processes.
• Support the controlled document system including review, approval, implementation, revision, distribution, and archiving of documents.
• Perform annual review of assigned controlled documents and update as needed.
• Write, review, and revise technical SOPs and policies; ensure alignment with regulatory and accreditation changes.
• Design and execute validation studies and develop related SOPs and worksheets; ensure validation meets regulatory endpoints.

• Oversee qualification of assigned SOPs and mentor team members involved in these activities.

   

Quality System Support

• Conduct quality assurance reviews of third party lab results, manufacturing batch records, and quality control testing records (environmental monitoring, sterility, batch data, and CBU documentation). Ensure corrective actions are addressed and files are closed appropriately.
• Complete final CBU reviews for registry listing, confirming donor eligibility, licensure status, and conformance to BLA specifications.
• Review products for release, ensuring all criteria, investigations, and documentation—including Certificates of Conformance—are complete prior to clinical distribution.
• Review product testing, follow up on outstanding results, resolve reactive/abnormal findings, and report to physicians or agencies as appropriate.
• Inspect and release lot labels; investigate labeling errors or missing labels.
• Support the automated monitoring system (daily/monthly review, alarm investigations, corrective actions, probe calibration management, and staff training).
• Ensure proper documentation of deviations, incidents, out of specification results, product recalls, and complaints. Oversee staff training and competency monitoring.
• Perform quality management review of deviations/incidents, identify issues, support investigations, and determine corrective/ preventive actions (CAPA). Track timely implementation.

• Support electronic submission of documentation for accreditation, licensing, and post marketing activities (clinical outcome data, changes, biological product deviations, adverse events, BLA, IND, CAP, FACT).

   

   

  Other duties as assigned.