• Ensure total operation is compliant with state and federal regulations (e.g., FDA approved SOPs, OSHA, CLIA, and GMP) to maintain the highest production standards and ensure facility compliance.
• Maintain a high level of customer service and positive donor experience in line with company values and culture.
• Stock and replenish supplies to meet production needs and maintain a clean, professional work environment.
• Review and confirm donor identification and maintain donor confidentiality per SOPs.
• Set up and prepare all equipment and disposable supplies for venipuncture and plasmapheresis procedure; label units and samples accurately.
• Execute venipunctures and plasma collection, maintaining the highest standards of quality and safety.
• Operate the automated plasmapheresis machines, including response and evaluation of all machine alarms and alerts, donor adverse events, document exceptions, etc.
• Monitor donor conditions, employing techniques to ensure donor comfort, safety, and the quality of plasma product.
• Maintain proper ratio to ensure donor safety and quality of product, disconnect donors, and manage the disposal of biohazard waste and contaminated equipment in accordance with the safety protocols.
• Perform daily, weekly, and monthly calibration and maintenance of automated plasmapheresis machines; remove and/or replace equipment from service as needed.
• Maintain accurate and thorough documentation, including Plasmapheresis Machine Logs, and report all unsafe situations and conditions to management.
• Drive training efficiencies to ensure timeliness and compliance.
• Troubleshoot machine alarms/alerts and perform QCs routinely (defined as daily/monthly) on equipment.
• Perform other duties as assigned.