Trane Technologies is hiring a Cell Therapy QA Specialist IV. In this critical role, you will manage the cleanroom facility, support the document control system, and oversee training, competency, audits, and incident reporting. Your work will ensure compliance with our Cord Blood Bank quality assurance program and all applicable regulatory and accreditation agency standards.
What You'll Do
- Manage cleanroom facility, support document control system, training, competency, audit and incident reporting.
- Review all quality documents for compliance with CBB quality assurance program, SOPs, policies, and regulatory/accreditation agencies.
- Coordinate development and implementation of internal and external audits in collaboration with the Cord Blood Bank Management Team.
- Review all batch records, quality control testing records, and complete final reviews of CBU records for unit listing on national and international stem cell registries.
- Review all CBU records, shipment documents and Certificates of Conformance prior to release of a unit for distribution and clinical use.
- Participate in continuous quality improvement of banking activities.
- Provide oversight of the CBB Environmental Monitoring (EM) program including establishment of sampling plans, routine trending, and excursion response procedures.
- Ensure environmental monitoring is performed, under both static and dynamic conditions, trended and acted upon.
- Collaborate with MD Anderson’s housekeeping department to ensure the cleaning of the facility to appropriate standards.
- Provide oversight for the qualification and quality control release testing for raw materials, in-process materials, components, and finished products.
- Manage automated monitoring system to include daily and monthly review of monitors, investigation of alarms, implementation of corrective actions.
- Drive corrective/preventative actions, ensuring work is complete and the labs remain in a state of control.
- Review and monitor performance indicator data relating to the cleanroom facility to identify, develop and implement quality and process improvements.
- Manage environmental excursion investigations.
- Develop, implement and manage training, qualification and monitoring of staff using the cleanroom facility.
- Ensure Employee and Environmental Health and Safety implications of CB banking activities are properly managed.
- Work closely with Institutional Facilities to ensure CBB cleanroom facility meets Biological Licensure requirements according to FDA guidelines.
- Perform quarterly safety inspections.
- Maintain current knowledge of technical procedures, policies and applicability of respective regulations and standards.
- Assist in the assessment, development and implementation of the training program; identify improvement areas and processes for training.
- Monitor the training and competency evaluation of CBB staff.
- Review and audit training and competency records for all activities under the CBB quality management program.
- Provide oversight of Proficiency Testing program, submit final reports and investigate failures, develop and implement corrective actions.
- Plan and implement educational in-services to improve staffs’ knowledge.
- Assist, guide and mentor employees assigned to performing SOP review and revisions.
- Support Controlled Document System and Standard Operating Procedure (SOPs) Development and Review.
- Contribute to the maintenance and management of document control system.
- Perform annual review of assigned controlled documents and associated controlled documents changes as necessary.
- Responsible for writing, reviewing and revising technical SOPs and policies as assigned.
- Design, direct execution and summarize designated validations, developing the corresponding SOPs and worksheets.
- Responsible for the qualification of assigned SOPs.
- Responsible for providing quality assurance reviews and ensuring compliance and completeness of 3rd party lab results, manufacturing batch records, and quality control lab testing records.
- Complete final review of CBU for listing on stem cell donor registries including confirming Donor Eligibility and licensure status as well as conformance of the CBU to all BLA specifications.
- Complete review of all products to confirm all release criteria are met prior to release for distribution and clinical use.
- Review testing of product; including follow-up of outstanding results, resolution of reactive/abnormal results, reporting to physicians and/or appropriate agencies as applicable.
- Responsible for inspection and release of lot labels as well as investigating events related to labeling errors or missing labels.
- Assist with the management of automated monitoring system.
What We're Looking For
- Previous experience working in the Cord Blood Bank at MD Anderson.
Team & Environment
Collaborate with the Cord Blood Bank Management Team.
Benefits & Compensation
- 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
Work Mode
This position is onsite in Houston, Texas.
Trane Technologies is an equal opportunity employer.
