Essential Functions

　　Support or serve as lead investigator for Out of Specifications results, identify and implement Corrective Actions.Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).Support or serve as lead investigator for Exceptions to Standard Operating Procedures.Generate or review Change Controls for Standard Operating Procedures, Standard Test Methods, Data Sheets, etc.Employ the use of quality tools (i.e. FMEA, Fishbone, 5 Why, Risk Analysis, HFAT, etc.) in support investigations and special projects.Perform statistical analysis of laboratory data in support of investigations, cost savings, continuous improvement initiatives.Generate, execute, and manage protocols for Method Validations, Equipment Qualifications Work with radioactive materials.Ensure a safe and quality working environment through training, awareness, and compliance to safety/Quality guidelines and SOPs.Maintain current knowledge of US and international regulations regarding Microbiology, Chemistry and cGMP's.Provide support for regulatory agency (i.e. FDA, HC, EU, TGA, etc.) on-site audits.