The Quality Assurance Coordinator for the Cell and Tissue Engineering Laboratory (CTEL) is responsible for establishing and maintaining quality assurance to fully support the production and clinical application of tissue, cellular and genetic therapies. Ensures delivery against Quality Unit goals and objectives by establishing and maintaining documentation demonstrating regulatory compliance and product consistency throughout all phases of development in the Good Manufacturing Practice (GMP) Cell and Tissue Engineering Laboratory at Westchester Medical Center which services the Blood and Marrow Transplant Program . Interprets and applies FDA and other applicable regulations and accreditation standards, such AS NYSDOH, College of American pathologists, Foundation for the Accreditation of Cellular Therapy and AABB. Assists the CTEL Laboratory Manager and CTEL Medical Director in the preparation of IND submissions to the FDA. Collaborates closely with the CTEL Laboratory Manager, Medical Director and BMT team to bring innovative therapies into clinical application by establishing sound quality systems. Serves as an organizational resource proactively raising awareness of regulatory changes and implementing operational revisions as necessary. Reports directly to the CTEL Medical Director.
10 years experience in cell processing/cellular therapies. Master's preferred in medical technology or one of the chemical or biological sciences and minimum of 10 years of clinical laboratory experience, preferably in cellular therapy and engineering, 5 of which must have been as a Supervisor or Quality Manager in an approved medical or hospital laboratory or meet the qualifications as a Medical Technologist pursuant to the provisions of Section 58-1.5(b) or title 10 of NYS Public Health Law.
Special Requirements: Possession of a valid license and current registration as a NYS clinical Laboratory Technologist, ASCP certification desired.
About Children's and Women's Physicians of Westchester
CWPW’s physicians are committed to providing integrated, comprehensive inpatient and outpatient care to infants, children, adolescents and adults right in your community. We have general pediatric primary care offices throughout the tristate metropolitan region which are closely coordinated with our extensive range of subspecialty services. In addition, we have adult specialists in gastroenterol...ogy, infectious diseases, nephrology, and obstetrics / gynecology providing the highest quality advanced care in the region.