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Background.  USAMMDA is the largest Department of Defense's (DoD) medical materiel development activity designed to protect and preserve the lives of Warfighters.  USAMMDA develops, modernizes, procures, and fields new drugs, vaccines, medical devices and support equipment that enhances readiness, ensuring the provision of the highest quality medical care to the DoD and maximizing survival of medical casualties on the battlefield.General.  The Contractor will provide quality assurance support to the USAMMDA Office of Quality Management. The Contractor will maintain the control system for quality documents (e.g., SOPs, Forms and Work Instructions) IAW the review and revision cycle. The Contractor will author, revise, review, and staff quality documents relating to various USAMMDA business processes and will ensure that appropriate personnel are trained in these processes and will track and maintain training records. The Contractor will lead and/or support internal/external audit, corrective and preventative action (CAPA), and inspection preparation activities, ensure the proper policies and procedures are in place, conduct gap assessments to identify improvement opportunities, and design, implementation, and evaluate compliant solutions. The Contractor will support the design, implementation and management of Continuous Process Improvement (CPI) initiatives intended to fill identified gaps or increase operational effectiveness and efficiency. The Contractor will support quality oversight programs such as the Risk Management Internal Control (RMIC) Program and the Command-wide Organizational Inspectional Program (OIP).   The Contractor will serve as the quality assurance representative on cross-functional, multi-site and multi-disciplinary teams (e.g., IPTs and working groups, USAMRDC Quality Working Group, etc.), and author, revise, review and staff documents to ensure initiatives follow industry best practices and are compliant with DoD/Army/AFC/USAMRDC policy, and all applicable regulations and guidance. The Contractor will provide input into the design and presentation of OQM performance metrics within the aforementioned Strategic Plan and/or USAMMDA Mission-Essential Task List (METL), and coordinate collection of all USAMMDA metrics.   Personnel performing in this task areas will have the ability to interpret and apply knowledge of applicable policies and regulations in order to assist with all aspects of USAMMDA’s compliance.