This role is responsible for executing the plasmapheresis process by performing venipunctures.
• 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 cleanliness and organization of work areas, stock adequate supplies, report all unsafe situations and conditions to management, and perform First-In-First-Out inventory tasks
• Review and confirm donor identification, monitor donor conditions, and uphold donor confidentiality to ensure safety, comfort, and product quality.
• Set up and prepare all equipment and disposable supplies for venipuncture and plasmapheresis procedure; maintain proper collection ratios and accurately label units and samples.
• Execute venipunctures and plasma collection, maintaining the highest standards of quality and safety.
• Operate automated plasmapheresis machines, respond to alarms, troubleshoot alerts, document exceptions, and manage donor adverse events.
• Disconnect donors and manage biohazard waste disposal between procedures, including cleaning spills and handling contaminated equipment in accordance with the safety protocols.
• Perform calibration/maintenance of automated plasmapheresis machines and remove and/or replace equipment from service, if needed.
• Maintains accurate and thorough documentation of necessary records, including Plasmapheresis Machine Logs.
• Mentor and train team members as a Designated Trainer, driving training efficiencies to ensure timeliness and compliance.
• Responsible for troubleshooting machine alarms/alerts and perform QCs routinely on equipment.
• Partner with Quality Assurance on donor floor performance, including favorable performance observations, CAPA implementations, and continuous improvement initiatives.
• Perform other duties as assigned.
• High school diploma or GED.
• Three (3) months’ experience in a medical or health care environment or equivalent combination of education and experience preferred.
• Completed documentation of training appropriate for duties, prior to performing duties independently.
• Any specific certification or licensing based on State requirements.
• Ability to sit or stand for extended periods.
• Ability to tug, lift, and pull up to thirty-five (35) pounds.
• Ability to bend, stoop, or kneel.
• Ability to utilize all required PPE (Personal Protective Equipment).
• Occupational exposure to blood borne pathogens.
• Ability to view video display terminal less than 18” away from face for extended periods.
• Ability to enter an environment with a temperature of -40C according to Standard Operating Procedures.
• Ability to perform precise tasks that require repetitive small motor skills, such as drawing blood for diagnostic tests.
• Ability to use assistive devices if needed for mobility or communication.
• Ability to use a computer and other office equipment.
• Ability to communicate effectively, both verbally and in writing.
• Ability to focus and concentrate on tasks for extended periods.
• Ability to navigate the office environment safely, including stairs and elevators (if applicable).
• Ability to travel up to 20% via airplane and vehicle (if applicable).
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