In this role, the selected candidate will create and present concise, factual case reviews including pertinent elements needed for evaluation and appropriate action by peer review committees, leadership, and quality improvement teams.
The incumbent exercises a role in monitoring and maintaining the external manufacturers/partners compliance with the FDC Act, Current Good Manufacturing Practices Regulations (domestic and foreign) and other pertinent legal requirements in accordance with Quality and Supply Agreement terms and Company Policy.
In this role, you will analyzes data and writes summaries to validate or show deviations from existing standards. Recommends modifications to existing, or suggests new, standards, methods and procedures. Works closely with the Quality Team to help identify, solve and prevent problems affecting quality.