Andrew C.

• Authored, conducted, and implemented various technical strategies and documents ranging from SOPs, CAPAs, Root Cause Analysis, CofAs, Change Control • Extensive knowledge of various aspects of the FDA and EPA codes and regulations • Understanding of USP, PhEur, JP, EP, BP, and other International Pharmaceutical Organizational standards, regulations, and compliances • In-depth knowledge of GMP, GLP, GCP, CLIA, and ICH Guidelines • Ability to perform various laboratory functions such as HPLC, GC, FTIR, UV-Vis, SEM, Thermal Desorption, physical chemistry analysis, wet chemistry analysis, and other compendial analysis