Job Details

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, repor...Specialist, Business Operations, Quality, Healthcare, Plasma