Cell Therapy QA Specialist IV - Melanoma Medical Oncology - Research

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.

KEY FUNCTIONS:

* Provides administrative leadership of standard of care (SOC), clinical research and Good Manufacturing Practices (GMP) workflows to ensure institutional compliance with federal agencies.

* Develops, implements, and conducts audits and reviews/analyzes data and documentation.

* Maintains documentation of tests, interprets results and prepares reports of critical quality metrics.

* Develops training and ensures laboratory follows good manufacturing practice (GMP) and standard operating procedures (SOPs).

* Ensures compliance with quality systems and standards.

* Consults and collaborates with the research team and principal investigators in all aspects of protocol management.

* Develops, implements and maintains Quality Assurance programs such as document control, deviation investigation, CAPA, audits, qualifications, validations, and training.

* Ensures investigational agent product quality and safety are in compliance with GMP and IND.

* Has thorough understanding of cell therapy manufacturing under GMP conditions.

* Knowledge of guidelines from federal agencies as it pertains to quality of cellular drug products.

* Maintains facility and equipment control, such as equipment maintenance and yearly calibrations (IQ,OQ,PQ).

* Provides assistance to clinical and principal investigators with the FDA and IRB application submissions and query responses.

* Participates in regulatory and accreditation agency inspections.

* Excellent written and verbal communication skills are required as well as the ability to work well in a collaborative and interdisciplinary team environment.

* Strong attention to detail, multi-tasking and a willingness to learn new technologies is encouraged.

Other duties as assigned.

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 working in a GMP facility with quality assurance. Experience with regulatory submissions with a manufacturing focus and quality of drug products. Thorough understanding of cell therapy manufacturing under GMP conditions and knowledge of FDA guidelines pertaining to quality of cellular drug products is a plus.

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