Independent level of quality inspection and control --ensures center compliance with quality standards and regulations. Collaborates with Center Managers to ensure product quality, donor suitability and donor safety.
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 donor center through recognition of trends, investigation of failures in the execution of procedures,
direct employee observation and review of center documents.
Responsible for the personnel functions of the Quality Associate(s); including direction, assignment of work, hiring, development and training, disciplinary actions, termination, maintenance of all personnel records,
management of work schedule and delegation/follow-up of tasks.
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.
Works in collaboration with the Center Manager to develop the staff’s knowledge of their job function and how their performance relates to the end product and patient.
Documents, investigates, and performs 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.
American Society For Quality - 12 months ago