Quality Assurance Specialist - GMP Laboratory

The University of Texas MD Anderson Cancer Center in Houston is one of the world's most respected centers focused on cancer patient care, research, education and prevention. It was named the nation's No. 1 hospital for cancer care in U.S. News & World Report's 2019 rankings. It is one of the nation's original three comprehensive cancer centers designated by the National Cancer Institute.

The primary purpose of the Quality Assurance Specialist position is to manage the Stem Cell Transplantation and Cellular Therapy (SCTCT) Laboratory compliance with Clinical Trials. Consults and collaborates with clinical investigators at UTMDACC and other sites involved in the trial. Write Chemistry Manufacturing and Control (CMC) sections of IND submissions for regulatory approval. Submit Laboratory section of Annual Report to Research Education and Regulatory Management.

KEY FUNCTIONS

Regulatory Compliance

a. Evaluate quality systems, regulatory compliance, and areas of product review and release, change control, documentation review and approval, as well as validation and maintain forms utilized by SCTCT laboratory staff.
b. Prepare CMC section of IND for regulatory submission.
c. Prepare Annual Report for submission to FDA.
d. Prepares and maintains the SCTCT Laboratory Master File.

Protocol Management

a. Write laboratory protocols for submission to IRB, submit data to sponsor when appropriate and have QA oversight of clinical trial. Primary contact with Clinical Trial Principle Investigators.
b. Responsible for clinical trial product release. Perform external audits.
c. Review Patient records after cellular infusion.

Other duties as assigned.

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 of 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.

Preferred: Five years of professional experience in a healthcare, or academic setting with at least one year of experience with research protocols, regulatory compliance and/or education and two years supervisory/team lead experience.

CERTIFICATION

Required: None

Preferred: Certification from the Association of Clinical Research Professionals (ACRP)

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