Proficiency in quality system management, cleanroom aseptic technique, culture-based microbiological lab techniques, microscopy, FTIR, endotoxin testing, sterility testing, environmental monitoring, data trending, root cause analysis, CAPA, technical writing, developing and reviewing SOPs, and familiarity with Microsoft 365, Google Drive, and various QMS, LIMS, and EMS interfaces. Proven record of accomplishment in developing and driving environmental monitoring programs, improving environmental controls, overseeing quarantine and release/rejection of goods, and promoting workplace safety.