QA Data/Document Review Associate at American… · Shirley

Summary: American Regent, Inc. is seeking a QA Data/Document Review Associate to ensure quality compliance in the review of cGMP analytical data for pharmaceutical processes. The role involves conducting quality assurance reviews, identifying process improvements, and ensuring adherence to company policies and FDA guidelines. Responsibilities: - Provides quality assurance review of laboratory raw data and reports including analytical worksheets, test summaries and stability summaries - Participates in identifying quality process improvements to increase efficiency and performance of systems, operations and personnel relating to the QA Data Review process - Writes and revises SOP’s and other GMP documentation as needed - Ensures all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP, compendia, and all applicable FDA Guidance document requirements and other company requirements - Participates in other Quality System activities with other team members as needed - Perform any other tasks/duties as assigned by management Required Qualifications: - Bachelor's degree in the Physical Sciences, Mathematics or related field, or Associate's Degree with experience in data review required - Minimum 2 years experience in a chemical testing, laboratory setting with a working knowledge of wet chemistry and instrumental analysis techniques, or at least 1 year of data review experience - Demonstrates extreme attention to detail to achieve quality results - Ability to perform multiple activities at the same time and produce outstanding results to meet required deadlines - Exercises a willingness to learn and take on added responsibilities as needed - Excellent organizational, interpersonal and communication skills (oral and written) to work in a team environment - Ability to work overtime as needed - Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves - Employee must be able to occasionally lift and/or move up to 25 pounds Required Skills: cGMP compliance, data review, wet chemistry Important Skills: instrumental analysis Benefits: Healthcare, Life insurance, Profit sharing, Paid time off, Matching 401k, A wide range of other benefits