The QCM will stay current on publications released by USP, FDA and other pertinent regulating bodies to ensure the Quality Control Analytical & Microbiology Laboratories and the Incoming Inspection departments are complaint in the areas of applications, release specifications, and documentation practices.
In this role, you will provide systems level guidance and instruction to the quality department as well as the overall operation to ensure that all are working towards the same set of goals and requirements.
In this role, you will be responsible for release of raw material, production support, finished product, and stability samples - Author and review laboratory investigation reports, deviations, and technical documents - Perform forecasting for resource and stability needs.
In this position, you will review all Medicare and other episodic payers clinical records at the local level to assure appropriate documentation for reimbursement. This review includes verification of appropriate documentation, quality of care provided, visits utilization, appropriate contacts with physicians, adherence to the care plan, and evidence of communication between disciplines.