Cell Therapy Integrated Service and QA Specialist-Vector Production Lab

Cell Therapy Integrated Service and QA Specialist-Vector Production Lab Location: METROHEALTH MEDICAL CENTER Biweekly Hours: 80.00 Shift: 8-4:30 Responsible for processing clinical and clinical research cellular therapy products for infusion into patients. The Cell Therapy Lab is responsible for processing and storage of cellular products for use in compliance with Good Clinical Practices (GCP), Food and Drug Administration (FDA), Current Good Manufacturing Practice (cGMP), Current Good Tissue Practices (cGTP), and Foundation for the Accreditation of Cellular Therapy (FACT) regulations. The laboratory supports the Stem Cell Transplant program of MetroHealth and somatic cell therapy clinical trials at MetroHealth, regional partners, and nationally. Additionally, the position provides quality assurance expertise and oversight to ensure compliance of complex programmatic activities with regulatory and accreditation agency laws and guidelines. Upholds the mission, vision, values, and customer service standards of The MetroHealth System. Qualifications Minimum of a BA/BS in biology, Medical Technology or other healthcare‑related field, or equivalent combination of education, training, and experience. 3 years laboratory experience in a healthcare‑related field. 3 years QA or quality compliance experience in a regulatory environment. Working knowledge of FDA, cGMP, cGTP, and GMP. Certification in Human Subjects Protection and HIPAA training within 3 months of hire. Familiarity with basic laboratory equipment and experience in aseptic technique, including cell culture. Excellent verbal and written communication skills, including the ability to effectively interface with physicians, nurses and laboratory personnel. Proficient in the use of the Microsoft Office Suite (Word, Excel, Access). Physical demands: may sit, stand, stoop, bend, and ambulate intermittently; may need to sit or stand for extended periods; normal visual and auditory range; finger dexterity to operate office equipment; ability to communicate face‑to‑face, phone, email and other communications; ability to see computer monitor and departmental documents. Preferred Qualifications Advanced degree. 5+ years laboratory and QA experience. Expert knowledge of FDA, cGMP, cGTP, and GMP. American Society of Clinical Pathology (ASCP) certification. #J-18808-Ljbffr The MetroHealth System