• Ensure total operation is compliant with state and federal regulations (e.g. FDA approved SOPs, OSHA, CLIA, and GMP).
• Uphold donor confidentiality in alignment with company values and SOPs.
• Review and confirm donor identification and employ techniques to ensure donor comfort, safety, and product quality.
• Set up and prepare equipment and supplies for venipuncture and plasmapheresis.
• Operate automated plasmapheresis machines, manage adverse donor events, perform QCs, and document exceptions.
• Disconnect donors and handle the disposal of biohazardous waste and contaminated equipment, including cleaning spills and following safety protocols.
• Perform calibration/maintenance of automated plasmapheresis machines and removes and/or replaces equipment from service, if needed.
• Maintain accurate and thorough documentation of necessary records.
• Maintain cleanliness and organization of work areas, stock adequate supplies, and perform inventory tasks such as First In, First Out.
• Report all unsafe situations and conditions to management.
• Mentor and train team members as a Designated Trainer, driving training efficiencies; upon completion of training, support QA-Backup or NexSys Technician duties as required.
• Partners with Quality Assurance on overall donor floor performance including favorable performance observations, CAPA implementations, and continuous improvement initiatives.
• Oversee the flow of donors, responsible for organizing lunch schedules, breaks, and overall schedule adherence.
• Perform other duties as assigned.