The individual should be capable of observing actual laboratory practices, interviewing analysts and management, reviewing raw analytical data and representative investigations, assessing analytical methods and laboratory controls, and determining whether the laboratory is operating in a state of control and whether the data it generates are scientifically sound, reliable, and suitable to support material and product release decisions. The consultant will evaluate laboratory operations, analytical methods, procedures, documentation, equipment, computerized systems, and quality controls for compliance with applicable current Good Manufacturing Practice (cGMP) requirements, United States Pharmacopeia (USP) requirements, and recognized pharmaceutical laboratory industry practices.