Quality Specialist - Plasma Center

Job description

Essential Job Responsibilities and Duties: - Perform donor record file review - Perform equipment quality control review - daily, weekly, monthly, semi-annual and annual - Review medical reports and communication - Perform reviews of equipment incidents - Verification and release of sample shipment - Responsible for the inspection and release of incoming supplies - Initiate deviation reports as needed - Perform Weekly employee observations - Assist the Manager of Quality Assurance with compliance of all state and federal regulations, FDA-approved Standard Operating Procedure Manual, Clinical Laboratory Improvement Amendments (CLIA), Current Good Manufacturing Practice (cGMP), Occupational Safety and Health Administration (OSHA), and internal company procedures - Reviews the documentation of unsuitable test results and the disposition of the associated units In the absence of the Manager of Center Quality Assurance: - Conduct root cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the donor and the quality of the product - Review of equipment records and donor system information, if applicable, to approve out of service equipment...