Cell Therapy Integrated Service and QA Specialist-Vector Production Lab

Qualifications

• Minimum of a BA/BS in biology, Medical Technology or other healthcare-related field or any equivalent combination of education, training, and experience in addition to the experience stated below.
• 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 of products, including Word, Excel, and Access.

Preferred

• Advanced degree.
• 5+ years laboratory and QA experience.
• Expert knowledge of FDA, cGMP, cGTP, and GMP.
• American Society of Clinical Pathology (ASCP) certification.

Physical Demands

May sit, stand, stoop, bend, and ambulate intermittently during the day. May need to sit or stand for extended periods. See in the normal visual range with or without correction. Hear in the normal audio range with or without correction. Finger dexterity to operate office equipment required. Ability to communicate in face-to-face, phone, email, and other communications. Ability to see computer monitor and departmental documents.