PURPOSE
Ensure suitability of plasmapheresis donors, through the use of the SOP, current FDA and State guidelines, OSHA, CLIA, cGMP, and all internal company procedures.
General Requirements - Adhere to all Standard Operating Procedures, Current Good Manufacturing Practices and Company Policies. Ensure donor suitability, product integrity, and continued good health of donors through the center's compliance with Food and Drug Administration (FDA) regulations, state regulations, the Standard Operating Procedure Manual guidelines of the Company and any other applicable regulatory standards.
ESSENTIAL RESPONSIBILITIES & DUTIES
Reporting and Accountability
Other Responsibilities
REQUIREMENTS
PHYSICAL DEMANDS
Performing the responsibilities of the job requires the ability to talk and hear. Regularly required to use hands and fingers, handle, or feel objects, tools or controls, and reach with the hands and arms. Frequently required to stand, for extended periods (2-3-hour intervals), walk, climb, or balance; and stoop, kneel, or crouch. Ability to read and type while sitting in front of a computer. Physically able to use and operate equipment used in assessing donor suitability as well as equipment used to harvest plasma. Manual dexterity to perform all phases of plasmapheresis. Ability to lift tug and pull up to 50 pounds.
WORK ENVIRONMENT
This job routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines. Occupational exposure to bloodborne pathogens and other conditions common to a donor center. Personal protective equipment is required such as eyewear, lab coats, and gloves.
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