• Ensure compliance with all state, federal, and industry regulations (e.g., FDA approved SOPs, OSHA, CLIA, GMP) to maintain production standards and facility compliance.
• Maintain high levels of customer service, donor confidentiality, and a positive donor experience.
• Monitor donor conditions and perform eligibility assessments, including vitals, microhematocrit, total protein testing, and donor registration, to ensure safety and product quality.
• Set up, prepare, and operate automated plasmapheresis equipment; respond to alarms, troubleshoot alerts, and disconnect donors upon procedure completion.
• Perform plasma collection and processing, including sterile product and sample handling, freezer organization, and preparation of shipments in compliance with SOPs and transportation regulations.
• Monitor freezer and refrigerator temperatures, report malfunctions, and document variances as required.
• Maintain cleanliness of the donor center and work areas, ensuring professional appearance, proper stocking, and safe disposal of biohazardous waste and spills.
• Maintain and perform quality control on donor center equipment according to SOPs and manufacturer instructions.
• Maintain complete and accurate recordkeeping in compliance with company SOPs.
• Provide oversight of product safety and quality by maintaining proper collection ratios, monitoring donor safety, and responding to adverse donor events.
• Troubleshoot machine issues and perform routine quality control checks on equipment.
• Perform other duties as assigned.