Ms. McCaffery is a Compliance Officer with the New Jersey District Office and has been with the FDA since 1995. She conducted domestic and foreign pharmaceutical inspections and is currently evaluating cases as a district Compliance Officer. She was a member of the Level III Pharmaceutical Inspectorate, Foreign Inspection Cadre, and New Jersey District Drug Cadre. She is on the Course Advisory Group for Level III Pharmaceutical Inspectorate and Positron Emission Tomography (PET). She is also trained in Process Analytical Technology, biotechnology, and completed an FDA cooperative Biomanufacturing Training Program at North Carolina State University. Ms. McCaffery participates on ICH workgroups, FDA Quality Systems workgroups, and participated on the Field Drug Committee for one year. She has served as an Acting Supervisory Investigator and Acting Compliance Officer in New Jersey District Office on multiple details and has piloted several collaborative FDA/Industry training initiatives. Ms. McCaffery received her Bachelor of Science degree in Biology from Villanova University and participated in a student cooperative program for a large pharmaceutical manufacturer. She was then employed by a biotechnology company in New Jersey before joining FDA.