AMVETS Jobs

SUMMARY

The primary role of the Quality Assurance Specialist position is to participate in all aspects the Cord Blood Bank quality assurance program, ensuring compliance with applicable regulatory and accreditation agencies. Review of quality records, participation in internal and external audit program, review and investigation of events/CAPA, monitor staff training and competencies, assist with document control and change control systems and conduct monitoring to ensure facility compliance with all regulatory requirements including, FACT, CAP, and FDA. Participate in continuous quality improvement of banking activities.

The ideal candidate will have a background in Quality Assurance/Control, hold professional certification as a Medical Laboratory Scientist (MLS), and possess experience in cord blood banking, blood banking, tissue banking, or clinical cell therapy/transplantation.

JOB SPECIFIC COMPETENCIES

Facility Quality Compliance

a. 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. 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. c. Maintain an aseptic processing monitoring program of both facility and personnel. d. Review and monitor performance indicator data relating to the cleanroom facility to identify, develop and implement quality and process improvements. e. Assist with the 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. f. Ensure Employee and Environmental Health and Safety implications of CB banking activities are properly managed as required by institutional and external regulatory guidelines. g. Work closely with Institutional Facilities to ensure CBB cleanroom facility meets Biological Licensure requirements according to FDA guidelines. h. 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 to ensure compliance with regulatory requirements. 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. Review Proficiency testing final reports, investigate failures and develop and implement corrective actions. e. Assist with the planning and implementation of 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. Contribute to the maintenance and management of document control system; including review, approval, implementation, revision,

distribution, archiving of documents and change control. h. As directed, write, review and revise technical SOPs and policies, ensuring they are updated to include regulatory and agency changes. i. Assist with the development of validation and study protocols. Assist, guide and mentor employees assigned to performing validations and studies.

Quality System Support

a. Responsible for performing 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. Review testing of product; including follow-up of outstanding results and resolution of reactive/abnormal results. c. Ensure proper documentation of deviations and incidents, accidents, out of specification results, product recall, and product complaints including staff training and monitoring of competencies. d. Perform quality management review of deviations and incidents, identify issues and problems, and assist in investigations, evaluating possible causes. Assist with corrective and preventative actions (CAPA) and in their timely implementation. e. Participate in audit program, including planning, training, management of audit reports, communication of deficiencies and follow up of action items.

EDUCATION

Required: Bachelor's degree in Healthcare, Nursing or a related healthcare field.

EXPERIENCE

Required: Three years of professional experience in a healthcare or academic setting with one year experience with research protocols, regulatory compliance or education. May substitute required education with additional years of equivalent experience or applicable degree on a one to one basis.

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: 168286

• Employment Status: Full-Time

• Employee Status: Regular

• Work Week: Day/Evening, Days, Evenings

• Minimum Salary: US Dollar (USD) 75,000

• Midpoint Salary: US Dollar (USD) 93,500

• Maximum Salary : US Dollar (USD) 112,000

• FLSA: exempt and not eligible for overtime pay

• Fund Type: Soft

• Work Location: Onsite

• Pivotal Position: Yes

• Referral Bonus Available?: No

• Relocation Assistance Available?: Yes

• Science Jobs: No

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