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 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.
Minimum Requirements
Required Certifications, Licenses, and Registrations
Knowledge, Skills, and Abilities
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 of time.
Ability to enter an environment with a temperature of -40C according to SOPs.
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 work daytime and evening hours, weekends, holidays, and extended shifts frequently.
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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