Teams at American Regent, Inc.

Performs pharmaceutical microbiology quality control testing on raw materials, in-process materials, finished products, and cleanroom environments. Conducts bioburden, endotoxin, environmental monitoring, microbial enumeration, and water testing. Supports microbiological method development, validation, aseptic process simulations, sterilization activities, and container closure studies. Prepares protocols, reviews data, writes reports, and maintains SOPs and test methods in compliance with FDA, cGMP, and cGLP requirements.