Other: Computer files organizational skills. Computer application skills. Ability to read and follow all company SOPs and guidelines and demonstrated knowledge of cGMP regulations. Ability to work effectively as a member of a team, interact with internal and external clients during client site audits, conducting vendor audits, and interact with all levels of employees at the site for training and team events. Ability to manage multiple priorities, problem-solve and meet deadlines. Excellent verbal and written communication skills and ability to respond effectively to change. Champion new procedures which will improve or add value to new and existing assays. Knowledge of compendial monographs, 21 CFR Part 11 requirements, ICH guidelines and ISO standards as they apply to a regulatory environment.