• Ensure compliance with all state, federal, and industry regulations (e.g., FDA approved SOPs, OSHA, CLIA, GMP) to maintain production standards and facility compliance.
• Deliver high-quality customer service and maintain a positive donor experience while safeguarding donor confidentiality.
• Assess donor eligibility, including vitals evaluation, Microhematocrit and Total Protein testing, and registration, in accordance with SOPs.
• Monitor donor conditions throughout donation to ensure safety, comfort, and product quality.
• Set up and operate plasmapheresis equipment, troubleshoot alarms, respond to adverse events, and disconnect donors after procedures.
• Collect, process, and store plasma products and samples in compliance with SOPs and federal transportation regulations, including freezer/refrigerator monitoring and variance reporting.
• Maintain donor center equipment through routine and periodic QC checks and manufacturer-recommended procedures.
• Maintain cleanliness of work areas, manage supplies, and ensure safe biohazard disposal.
• Provide accurate and complete recordkeeping in compliance with SOPs and company policy.
• Mentor and train staff as a Designated Trainer; partner with Quality Assurance on floor performance, Corrective and Preventive Action (CAPA) implementation, and continuous improvement initiatives.
• Perform inventory-related tasks, including First-In-First-Out procedures, to ensure product quality and availability.
• Perform other duties as assigned.