Komen Graduate Training Program UT MDACC · 1 day ago
Cord Blood Bank Quality Coordinator - Equipment Management
Houston, TX
Full-time
Onsite
Mid Level
$67K/yr - $100K/yr
3+ years expThe Komen Graduate Training Program at UT MD Anderson is focused on creating lifesaving products from umbilical cord blood. The Cord Blood Bank Quality Coordinator is responsible for managing equipment and facility monitoring systems to ensure quality and regulatory compliance in the production of cord blood products.
Hospital & Health Care
Responsibilities
Lead equipment and facility management activities, including qualification, calibration, maintenance, and documentation for all CBB equipment to support uninterrupted operations and regulatory readiness
Coordinate vendor activities and service contracts, schedule and track on-site calibrations and repairs, and ensure all records are accurate, complete, and readily available for review
Develop, write, review, and revise SOPs and technical documentation related to equipment, reagents, and supplies, ensuring alignment with evolving regulatory and accreditation requirements
Manage electronic inventory and equipment tracking systems, including receipt, quarantine, lifecycle data, and retirement of equipment, in partnership with QA and procurement
Perform and/or coordinate IQ, OQ, and PQ for new and existing equipment, manage facility and equipment monitoring systems, and investigate and document alarm situations and deviations
Review daily, weekly, and monthly equipment and quality control logs, environmental monitoring data, sterility results, and media qualifications; trend data and contribute to root cause investigations and corrective actions
Create and review product qualification sheets for new supplies and reagents, contribute to risk assessments, and support validation and qualification studies in a timely and compliant manner
Provide regular status updates and metrics on equipment and quality performance to CBB leadership and actively participate in internal audits, external inspections, and quality management reporting
Train, mentor, and serve as a technical resource for staff on equipment use, maintenance, qualification processes, and documentation expectations
Perform additional duties as needed
Qualification
Required
Bachelor's degree
Three years of experience in cord blood collection, administration, or laboratory. May substitute required education degree with additional years of equivalent experience on a one to one basis
Quality control experience in a clinical, cell therapy, or cGMP laboratory setting
Proficient in performing routine quality control activities with laboratory instrumentation
Hands-on experience in regulatory laboratory or manufacturing environments
Strong understanding of cGMP manufacturing practices regulated by the FDA
Clinical laboratory experience including troubleshooting of clinical lab equipment
Experience in a regulated laboratory, biomanufacturing, blood bank, or cellular therapy environment with exposure to quality systems and documentation
Working knowledge of Good Laboratory Practices, Good Manufacturing Practices, Good Tissue Practices, and accreditation standards such as FACT/NetCord and CAP
Demonstrated ability to manage multiple pieces of complex equipment, coordinate service providers, and maintain accurate, inspection-ready records
Strong analytical and problem-solving skills, including experience reviewing trend data, investigating deviations, and supporting root cause and corrective action activities
Excellent attention to detail, organization, and follow-through, with the ability to prioritize and meet deadlines in a dynamic, high-stakes environment
Clear written and verbal communication skills and a collaborative approach to working with QA, operations, vendors, and leadership
Commitment to quality, patient safety, and continuous improvement in support of life-saving therapies
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
Excellent benefits , including medical, dental, paid time off , retirement , tuition benefits, educational opportunities, and individual and team recognition
Company
Komen Graduate Training Program UT MDACC
Through generous funding from Susan G.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase