Cell Therapy Quality Assurance Specialist IV - Cord Blood Bank
- Requisition #: 173160
- Department: Cord Blood Bank Program
- Location: Houston, TX
- Posted Date: 2/10/2025
The mission of The University of Texas M. D. Anderson Cancer Center is to eliminate cancer in Texas, the nation, and the world through outstanding programs that integrate patient care, research and prevention, and through education for undergraduate and graduate students, trainees, professionals, employees and the public.
SUMMARY
The primary role of the Quality Assurance Specialist position is to manage cleanroom facility, support document control system, training, competency, audit and incident reporting in compliance with the Cord Blood Bank quality assurance program and applicable regulatory and accreditation agencies including but not limited to FDA, FACT, and CAP. Review all quality documents for compliance with CBB quality assurance program, standard operating procedures and policies, as well as 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.
KEY FUNCTIONS
Environmental Monitoring and Facility Quality Compliance
a. Provide oversight of the CBB Environmental Monitoring (EM) program including establishment of sampling plans, routine trending, and excursion response procedures in accordance with applicable regulatory guidelines and the CBB Quality Management plan. Ensure environmental monitoring is performed, under both static and dynamic conditions, including during production of the biological product, trended and acted upon, to include, but not limited to, microbiological and particle levels. Collaborate with MD Anderson's housekeeping department to ensure the cleaning of the facility to appropriate standards by staff who are trained and competent to clean and sanitize the classified areas. b. Provide oversight for the qualification and quality control release testing for raw materials, in-process materials, components, and finished products in accordance with cGMP regulations, regulatory filings and approved procedures, including growth promotion testing for all media used in microbiology and EM program. c. Manage automated monitoring system to include daily and monthly review of monitors, investigation of alarms, implementation of corrective actions when applicable, management of annual probe calibrations and training of employees on use of system. d. Maintain an aseptic processing monitoring program of both facility and personnel. Drive corrective/preventative actions, ensuring work is complete and the labs remain in a state of control. e. Review and monitor performance indicator data relating to the cleanroom facility to identify, develop and implement quality and process improvements. Manage environmental excursion investigations. Ensure corrective actions identified for the investigation are implemented in a timely manner and monitored as part of the monthly trending meetings. f. Develop, implement and manage training, qualification and monitoring of staff using the cleanroom facility, including, but not limited to, access, gowning, hygiene, aseptic technique, cleanroom behavior and patient safety hazards posed by a non-sterile biological drug product. g. Ensure Employee and Environmental Health and Safety implications of CB banking activities are properly managed as required by institutional and external regulatory guidelines. h. Work closely with Institutional Facilities to ensure CBB cleanroom facility meets Biological Licensure requirements according to FDA guidelines. i. Perform quarterly safety inspections. Communicate deficiencies and ensure follow up of action items.
Quality Program Management
a. Maintain current knowledge of technical procedures, policies and applicability of respective regulations and standards including but not limited to FDA's current Good Tissue Practices and Good Manufacturing Practices, standards set by accreditation agencies including but not limited to FACT-NetCord and CAP. Ability to educate staff on the technical principles as well as applicable regulatory requirements defined in policies and procedure. b. Assist in the assessment, development and implementation of the training program; identify improvement areas and processes for training. c. 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. d. Provide oversight of Proficiency Testing program, submit final reports and investigate failures, develop and implement corrective actions. e. Plan and implement educational in-services to improve staffs' knowledge of their direct activities and understanding of the wider aspects of Cord Blood Banking, Transplantation and cord derived cellular therapies. f. Assist, guide and mentor employees assigned to performing SOP review and revisions. g. Support Controlled Document System and Standard Operating Procedure (SOPs) Development and Review. Contribute to the maintenance and management of document control system; including review, approval, implementation, revision, distribution and archiving of documents. h. Perform annual review of assigned controlled documents and associated controlled documents changes as necessary. i. Responsible for writing, reviewing and revising technical SOPs and policies as assigned, ensuring they are updated to include regulatory and agency changes. j. Design, direct execution and summarize designated validations, developing the corresponding SOPs and worksheets. Ensure validation will meet all required regulatory endpoints. k. Responsible for the qualification of assigned SOPs. Assist, guide and mentor employees assigned to performing such studies.
Quality System Support
a. 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 including, but not limited to, environmental monitoring data, sterility data, batch records, and CBU file completeness, suitability for listing, donor eligibility and licensure status. This includes following-up to ensure any corrective actions are compliantly addressed and files are properly closed.
b. 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. c. Complete review of all products, including internal quality assessments, to confirm all release criteria are met, any incidents have been investigated and closed, and shipment documentation including Certificates of Conformance, are complete prior to release for distribution and clinical use. d. Review testing of product; including follow-up of outstanding results, resolution of reactive/abnormal results, reporting to physicians and/or appropriate agencies as applicable. e. Responsible for inspection and release of lot labels as well as investigating events related to labeling errors or missing labels. f. Assist with the management of automated monitoring system to include daily and monthly review of monitors, investigation of alarms, implementation of corrective actions when applicable, management of annual probe calibrations and training of employees on use of system. g. Ensure proper documentation of deviations and incidents, accidents, out of specification results, product recall, and product complaints including staff training and monitoring of competencies. h. Perform quality management review of deviations and incidents, identify issues and problems, and assist in investigations, evaluating possible causes. Identify corrective and preventative actions (CAPA) and assist in their timely implementation. i. Participate in audit program, including planning, training, management of audit reports, communication of deficiencies and follow up of action items. j. Assist in the assessment, development and implementation of the training program; identify improvement areas and processes for training. Plan and implement educational in-services to improve staffs' knowledge of their direct activities and understanding of the wider aspects of Cord Blood Banking, Transplantation and cord derived cellular therapies. k. Support the electronic submission of required documentation for accreditation, licensing and post marketing activities such as clinical outcome data, change, biological product deviations and adverse experiences, including but not limited to FDA Biologics Licensure Application (BLA), Investigational New Drug (IND) applications, CAP, and FACT.
EDUCATION
Required:
Bachelor's degree.
Preferred:
Master's degree.
EXPERIENCE
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.
It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html
Additional Information
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SUMMARY
The primary role of the Quality Assurance Specialist position is to manage cleanroom facility, support document control system, training, competency, audit and incident reporting in compliance with the Cord Blood Bank quality assurance program and applicable regulatory and accreditation agencies including but not limited to FDA, FACT, and CAP. Review all quality documents for compliance with CBB quality assurance program, standard operating procedures and policies, as well as 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.
KEY FUNCTIONS
Environmental Monitoring and Facility Quality Compliance
a. Provide oversight of the CBB Environmental Monitoring (EM) program including establishment of sampling plans, routine trending, and excursion response procedures in accordance with applicable regulatory guidelines and the CBB Quality Management plan. Ensure environmental monitoring is performed, under both static and dynamic conditions, including during production of the biological product, trended and acted upon, to include, but not limited to, microbiological and particle levels. Collaborate with MD Anderson's housekeeping department to ensure the cleaning of the facility to appropriate standards by staff who are trained and competent to clean and sanitize the classified areas. b. Provide oversight for the qualification and quality control release testing for raw materials, in-process materials, components, and finished products in accordance with cGMP regulations, regulatory filings and approved procedures, including growth promotion testing for all media used in microbiology and EM program. c. Manage automated monitoring system to include daily and monthly review of monitors, investigation of alarms, implementation of corrective actions when applicable, management of annual probe calibrations and training of employees on use of system. d. Maintain an aseptic processing monitoring program of both facility and personnel. Drive corrective/preventative actions, ensuring work is complete and the labs remain in a state of control. e. Review and monitor performance indicator data relating to the cleanroom facility to identify, develop and implement quality and process improvements. Manage environmental excursion investigations. Ensure corrective actions identified for the investigation are implemented in a timely manner and monitored as part of the monthly trending meetings. f. Develop, implement and manage training, qualification and monitoring of staff using the cleanroom facility, including, but not limited to, access, gowning, hygiene, aseptic technique, cleanroom behavior and patient safety hazards posed by a non-sterile biological drug product. g. Ensure Employee and Environmental Health and Safety implications of CB banking activities are properly managed as required by institutional and external regulatory guidelines. h. Work closely with Institutional Facilities to ensure CBB cleanroom facility meets Biological Licensure requirements according to FDA guidelines. i. Perform quarterly safety inspections. Communicate deficiencies and ensure follow up of action items.
Quality Program Management
a. Maintain current knowledge of technical procedures, policies and applicability of respective regulations and standards including but not limited to FDA's current Good Tissue Practices and Good Manufacturing Practices, standards set by accreditation agencies including but not limited to FACT-NetCord and CAP. Ability to educate staff on the technical principles as well as applicable regulatory requirements defined in policies and procedure. b. Assist in the assessment, development and implementation of the training program; identify improvement areas and processes for training. c. 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. d. Provide oversight of Proficiency Testing program, submit final reports and investigate failures, develop and implement corrective actions. e. Plan and implement educational in-services to improve staffs' knowledge of their direct activities and understanding of the wider aspects of Cord Blood Banking, Transplantation and cord derived cellular therapies. f. Assist, guide and mentor employees assigned to performing SOP review and revisions. g. Support Controlled Document System and Standard Operating Procedure (SOPs) Development and Review. Contribute to the maintenance and management of document control system; including review, approval, implementation, revision, distribution and archiving of documents. h. Perform annual review of assigned controlled documents and associated controlled documents changes as necessary. i. Responsible for writing, reviewing and revising technical SOPs and policies as assigned, ensuring they are updated to include regulatory and agency changes. j. Design, direct execution and summarize designated validations, developing the corresponding SOPs and worksheets. Ensure validation will meet all required regulatory endpoints. k. Responsible for the qualification of assigned SOPs. Assist, guide and mentor employees assigned to performing such studies.
Quality System Support
a. 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 including, but not limited to, environmental monitoring data, sterility data, batch records, and CBU file completeness, suitability for listing, donor eligibility and licensure status. This includes following-up to ensure any corrective actions are compliantly addressed and files are properly closed.
b. 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. c. Complete review of all products, including internal quality assessments, to confirm all release criteria are met, any incidents have been investigated and closed, and shipment documentation including Certificates of Conformance, are complete prior to release for distribution and clinical use. d. Review testing of product; including follow-up of outstanding results, resolution of reactive/abnormal results, reporting to physicians and/or appropriate agencies as applicable. e. Responsible for inspection and release of lot labels as well as investigating events related to labeling errors or missing labels. f. Assist with the management of automated monitoring system to include daily and monthly review of monitors, investigation of alarms, implementation of corrective actions when applicable, management of annual probe calibrations and training of employees on use of system. g. Ensure proper documentation of deviations and incidents, accidents, out of specification results, product recall, and product complaints including staff training and monitoring of competencies. h. Perform quality management review of deviations and incidents, identify issues and problems, and assist in investigations, evaluating possible causes. Identify corrective and preventative actions (CAPA) and assist in their timely implementation. i. Participate in audit program, including planning, training, management of audit reports, communication of deficiencies and follow up of action items. j. Assist in the assessment, development and implementation of the training program; identify improvement areas and processes for training. Plan and implement educational in-services to improve staffs' knowledge of their direct activities and understanding of the wider aspects of Cord Blood Banking, Transplantation and cord derived cellular therapies. k. Support the electronic submission of required documentation for accreditation, licensing and post marketing activities such as clinical outcome data, change, biological product deviations and adverse experiences, including but not limited to FDA Biologics Licensure Application (BLA), Investigational New Drug (IND) applications, CAP, and FACT.
EDUCATION
Required:
Bachelor's degree.
Preferred:
Master's degree.
EXPERIENCE
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.
It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html
Additional Information
- Requisition ID: 173160
- Employment Status: Full-Time
- Employee Status: Regular
- Work Week: Day/Evening, Days, Evenings
- Minimum Salary: US Dollar (USD) 88,200
- Midpoint Salary: US Dollar (USD) 110,500
- Maximum Salary : US Dollar (USD) 132,300
- FLSA: exempt and not eligible for overtime pay
- Fund Type: Soft
- Work Location: Onsite
- Pivotal Position: Yes
- Referral Bonus Available?: Yes
- Relocation Assistance Available?: Yes
- Science Jobs: No
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