Description

Quality Engineer II is a quality assurance professional with substantial prior experience of working within a Quality or Manufacturing organization in a highly regulated industry. This individual specializes in evaluation of production processes and performance in manufacturing and participates in projects to engineer quality improvements of existing production processes as well as the development of new processes to improve quality and efficiency. Other job duties include but are not limited to understanding contamination/cross-contamination, observing aseptic practices, performing daily GEMBAs of manufacturing areas, continuously assessing fit and finish of the facility, and performing compliance inspections within manufacturing areas. This role supports Manufacturing by providing Quality input as needed, and requesting the initiation of deviations as they are identified. All activities are in support of producing and releasing quality bulk drug substance for clin...