Yaseli Soto

• Under general direction, monitors plasma center processes to ensure compliance with Standard Operating Procedures (SOPs) and applicable local, state and federal requirements
  • Partners with management to have the center “inspection ready” at all times by managing compliance to SOPs and the quality system
  • Ensures compliance to quality processes, regulatory requirements, SOPs and necessary training for plasma center and business operations
  • Coordinates training and facilitates processes to support timely reporting of biologic product deviations to Food & Drug Administration (FDA)
  • Performs/ensures center records quality review to ensure thoroughness, accuracy and timeliness of required information
  • Initiates investigation to ensure documentation of deficiencies and development of corrective action plans, in partnership with management
  • Ensures training materials/documents are maintained and modified regularly; maintains the Learning Management System to ensure data integrity, report generation and data analysis
  • Leads internal audits to monitor facility compliance with SOPs, cGMP, OHSA, FDA, and other regulations, as applicable

• In compliance with SOPs, performs all aspects of the pheresis procedure and plasma collection, including donor set-up, donor monitoring and donor disconnect.
• In compliance with SOPs and Food & Drug Administration (FDA) guidelines, performs venipuncture on donors to begin pheresis process.
• Evaluates vein performance of the donor to identify possible problems; makes necessary corrections in order to expedite donation time and ensure product quality and donor safety.
• Ensures donation process is efficient and makes adjustments when necessary to make the process a positive experience for the donor.
• Educate new donors on the use of therapeutic products made from donated plasma. Explains the screening process, the health screening tests performed, the appointment system, donation fees, center policies, proper nutrition and any other information pertinent to the donor. Ensures that all donor questions are answered timely, accurately and professionally.
• Maintains alertness to any reaction by donors and assists with reactions or notifies appropriate staff.
• Uses Personal Digital Assistant (PDA) to record incidents that occur during the pheresis process, such as machine alerts and alarms, volume variances and donor adverse events.
• Required to perform calibrations and verify that maintenance has been performed as outlined in the SOPs. Required to respond to and resolve complex equipment alarms or donor issues.
• Troubleshoots equipment failures. Creates incident documentation, removes and/or replaces equipment from service.
• Monitors donor flow on the donor floor to assure continuous turnover. Alerts Group Leader of Supervisor of donor flow issues.
• Collects arm samples or whole blood samples from donors for testing.
• Ensures the accurate recording of donor data in the electronic donor information management system as outlined in the Standard Operating Procedures (SOPs).
• Maintains clean efficient work environment, and ensures sufficient operating supplies and forms are available as needed.
• Follows all Health Safety & Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Promotes safety in all actions.
• Maintains confidentiality of all personnel, donor and center information.

• Greeted patients and visitors at the front desk.
• In compliance with Standard Operating Procedures (SOPs), assists qualified donors in completing the screening process.
• Educated new donors on the use of therapeutic products made from donated plasma. This includes explaining the screening process, the health screening tests performed, the appointment system, donation fees, center policies, proper nutrition, and any other information pertinent to the donor.
• Involved in registering applicant and transfer donors
• Answered the telephone and answered callers questions or transfer call to appropriate staff member.
• Maintain alertness and awareness to any reaction by a donor may have during or after the pheresis process and notifies appropriate staff.
• Alerts Group Leader or Supervisor of donor flow issues.
• Ensure the accurate recording of donor data in the electronic donor information management system as outlined in the SOPs.
• Understand the policies and procedures associated with hyper immune programs at the center if applicable.
• Maintains clean efficient work environment and ensures sufficient operating supplies and forms are available as needed. Follows all Health Safety & Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Promote safety in all actions.
• Maintain confidentiality of all personnel, donor and center information.

• In compliance with Standard Operating Procedures (SOPs), responsible for collecting plasma samples and moving plasma units to freezer to ensure product quality.
• Ensure plasma units are properly stored according to SOPs, which could include unsuitable plasma units and samples.
• Ensures accuracy of unit labeling by verifying the pre-printed label matches the dynamic label.
• Utilize sterile technique to draw samples and use heat sealer to assure the sterility and quality of plasma unit samples per SOPs.
• Ensure samples and units are packed and shipped in accordance with SOPs and center procedures. Prepares shipping and unit disposal documentation.
• Monitor freezer and refrigerator temperatures and immediately informs appropriate personnel if equipment is not functioning properly. Records variances.
• Conduct daily calibration of equipment according to SOPs.
• Ensure the accurate recording of donor data in the electronic donor information management system as outlined in the SOPs.
• Maintains clean efficient work environment, and ensures sufficient operating supplies and forms are available as needed. Follows all Health Safety & Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Promotes safety in all actions.
• Maintain confidentiality of all personnel, donor and center information.

• Processed donor information for plasma collection and maintained accurate records.
• Ensured compliance with safety protocols during donor interactions and procedures.
• Operated and calibrated equipment for plasma collection to ensure efficiency.
• Educated donors on procedures, eligibility, and post-donation care guidelines.
• Assisted in training new staff on donor support techniques and operational standards.
• Collaborated with team members to optimize workflow during busy donation periods.
• Monitored donor reactions and provided immediate assistance when necessary.
• Implemented quality control measures to maintain high standards in donor experience.

• Responsible for preparing the donor, donor area and equipment for the pheresis process.
• Prepares the autopheresis machine for the pheresis process.
• Monitors the donor and the pheresis process, responds to specific alarms or signals that may occur during the process.
• Disconnects the donor when the process is complete.

• Supervised cashier team to ensure efficient customer transactions.
• Trained new cashiers on point-of-sale systems and customer service standards.
• Managed cash register operations and balanced drawers at shift end.
• Assisted customers with product inquiries and resolved payment issues.
• Monitored inventory levels at the cash register area for accurate stock management.
• Collaborated with management on promotional activities and store events.
• Performed daily opening and closing procedures for the register area.
• Maintained a clean work environment by sweeping floors and wiping down counters regularly.
• Processed refunds and exchanges according to company policy.