The Quality Assurance Specialist will perform a wide variety of activities to ensure compliance with applicable regulatory requirements by conducting data and document reviews and analysis. Writes and revises SOPs and related manufacturing documents. Will review investigations related to manufactured product. Works on problems of complexity and diversity in which analysis of data requires in depth evaluation of various factors.
BS degree in a life science/scientifically related field and a demonstrated knowledge of scientific principles. Minimum of 6 years related work experience in a regulated environment, five years’ experience with lot release functions. Experience in technical writing and the ability to interface with internal clients is a must. Ability to effectively prioritize in a changing environment. Must be able to function independently with minimal direct supervision.