Stability Coordination

Education and Experience: Bachelor's Degree in Life Sciences or Physical Science field. II. Essential Functions Labeling, organizing and tracking the flow of documents, including spreadsheets, reports, protocols etc. Authors documents, such as stability protocols, text reports, certificates of analysis, and operating procedures Performs parallel review of documentation and may become qualified to perform technical review of documents for accuracy, thoroughness and regulatory compliance. Develop and execute stability work plans/schedules independently, using customer milestones and Division/site performance standards and metrics. Review technical documents for accuracy, thoroughness and regulatory compliance Identifies opportunities for improvement projects. Perform activities under cGMP as appropriate. Associate Scientist II under general supervision, performs work that is varied and that may be somewhat difficult in character, but usually involves limited responsibility. Some evaluation, originality or ingenuity is required. Follows established protocols and work plans. May be assisted by laboratory technicians / assistants. Comply with divisional and site Environmental Health and Safety requirements.