Additional Responsibilities Include:
◾Reviews SOPs to ensure that the most recently approved SOP procedures and forms are in the center procedure manuals and in use.
◾Complies with federal, state, local and company-specific regulations related to quality of product, employee and donor safety and to the proper performance of day-to-day activities.
◾Reviews equipment calibration, validation, and maintenance records to ensure they are performed correctly and on time.
◾Reviews freezer and refrigerator charts and temperature records for compliance with SOP.
◾Performs QA review of external sample and product shipment releases and shipping records.
◾Performs QA review of training records to ensure compliance with SOP, training manual and regulations.
◾Performs QA review of deviation reports.
◾Ensures the Donor Center’s licenses and certificates are in-date and valid.
◾Reviews donor record files daily per DCOP instruction.
◾Reviews of all product destruction records for compliance with SOPS.
◾Stages plasma units for shipment, requires pulling plasma cases in and out of freezer.