Essential Functions:
• Oversee the daily operations of the Stem Cell lab such as cryopreservation, freezing and thawing of products, record review, etc.
• Process cellular therapy according to SOP and good manufacturing practices in compliance with federal, state, and any other voluntary accreditation agency
• Issue of cellular therapies for reinfusion to the appropriate patient according to SOP and good manufacturing practices in compliance with federal, state, and any other voluntary accreditation agency
• Monitor and ensure compliance with rules and regulations established by internal and external regulatory agencies (NYS, OSHA, CAP, etc.)
• Assist manager with continuous internal assessments of the Stem Cell Laboratory through auditing. Offer long term solutions to issues found
• Develop and maintain a Stem Cell Laboratory Standard of Procedure Manuals (in cooperation with the Director and Manager). Monitor effectiveness of SOP
• Educate, train and routinely inservice Stem Cell and Blood Bank associates in the following (but not limited to): stem cell issue processing, cryopreservation and reinfusion of bone marrow and peripheral blood stem cells and immune effector cells, quality issues and good manufacturing practices; monitoring of freezers alarm system
• Develop, implement and reinforce Inventory Control and assure adequacy of quality control procedures
• Assist manager with a Stem Cell Laboratory disaster control plan and perform maintenance and delegate repair of all equipment when applicable
• Ensure record keeping is in compliance to regulatory agencies
• Help develop and maintain an adequate budget
• Keep current with new technology. Implement when applicable
• Assist manager with review of effectiveness of all corrective action plans