Cell Therapy Quality Assurance Specialist IV - Cord Blood Bank

About the role

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.

Responsibilities

• 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.
• 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.
• 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.
• 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).

Qualifications

• Required: Bachelor's degree.
• Preferred: Master's degree.
• Required: Five years of relevant experience. With Master's degree, three years of required experience required.
• PREFERRED: Experience with HCT/Ps in a quality control, quality assurance, or regulatory role. Experience manufacturing or testing clinical cellular therapy products. Experience in blood or tissue banking.

Skills

• Strong understanding of regulatory guidelines and standards (e.g., FDA cGTP, cGMP, FACT NetCord, CAP).
• Excellent communication and collaboration skills.
• Proficient in Microsoft Office Suite.
• Ability to perform detailed record keeping and analysis.
• Knowledge of cleanroom operations and aseptic techniques.

Benefits

• 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

Pay

Minimum Salary: US Dollar (USD) 88,200
Midpoint Salary: US Dollar (USD) 110,500
Maximum Salary: US Dollar (USD) 132,300

Schedule

Full-time, Day/Evening, Days, Evenings