Ensures that accurate and thorough documentation of necessary records is performed.Maintains active communication with other service areas to ensure accurate documentation and quality. Submit timely and accurate reports. Assist in the control of center donor funds. Assist in the training of new employees and retraining of current employees. Learn and maintain thorough familiarity and compliance with all state and federal regulations, U.S. Food and Drug Administration (FDA)-approved Standard Operating Procedure Manual, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), Current Good Manufacturing Practice (cGMP) and internal company procedures.
Independent level of quality inspection and control --ensures center compliance with quality standards and regulations. Directs and monitors processes and ensures center compliance with all applicable state, federal, and company-designated regulations.
Ensures that Standard Operating Procedures (SOPs) are properly interpreted, implemented in a timely fashion, and that the staff performs according to all SOPs.
Interprets and implements processes, regulations and SOPs for quality control and overall regulatory compliance, making independent decisions and modifications as required.
Oversight of all aspects of internal and external audits including execution (if applicable). This includes documentation, review of and preparation of the response.
Continuously assesses, promotes, and improves the effectiveness of the quality systems in the center through recognition of trends, investigation of failures in the execution of procedures, direct employee observation and review of center documents.
Oversees product and biohazard waste shipments: Ensures shipments meet regulatory specifications and product release requirements; ensures accurate labeling and documentation; and, authorizes final shipment.
Performs a review of the documentation of unsuitable test results and the disposition of the associated results. Documents, investigates, and performs root cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the patient and the quality of the product.