Quality Assurance Specialist - Stem Cell Transplantation Research

Employer
University of Texas MD Anderson Cancer Center
Location
Houston, Texas
Salary
Competitive
Closing date
Jul 8, 2022

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Discipline
Health Sciences
Organization Type
Healthcare/Hospital
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 Quality Assurance Specialist provides quality assurance related duties for the Department of Stem Cell Transplantation and Cellular Therapy, Cell Therapy Laboratory, and Adoptive Cell Therapy Platform related IND studies. This role impacts regulatory compliance and quality assurance relating to Investigational New Drug (IND) studies.

KEY FUNCTIONS

Regulatory Compliance

a. Reviews manufacturing records and test reports for multiple IND studies

b. Releases products for infusion into patients enrolled under IND studies

c. Prepare CMC section of IND studies for submission to the FDA

d. Prepares annual reports for IND studies

e. Prepares documents for review as requested by IND study monitors

f. Responsible for document review, change control and approval for Standard Operating Procedures (SOPs)

g. Available 24/7 to prepare documents for submission to the FDA for various IND studies as needed

Quality Assurance

a. Management of Event Tracking Reports, including tracking, data gathering, review, investigation and close-out. Determination of the need for Quality Investigation and CAPA.

b. Writes the Chemistry Manufacturing and Control (CMC) section of IND submissions for regulatory approval.

c. Reviews and approves Validation Plans and Validation Summary Reports.

Marginal Job Functions

Other duties as assigned by the Manager.

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

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