MAJOR DUTIES AND RESPONSIBILITIES include the following and other duties as assigned. Key Job Responsibilities: Coordinate site wide document control systems and processes to ensure their integrity and compliance with regulations. (FDA, OSHA, EPA, DEA, and Curia policies and procedures). Examples include: QC records (raw material, intermediate, finished product releases). Test methods, specifications, validation protocols, and all report. QC calibration and qualification documents. Master Batch Records Specialist Instructions Ensure that documentation/records are indexed, filed, archived, retrievable and issued, consistent with AMRI procedures and policies. Maintain an organized filing system for both hard copies and electronic files including onsite and offsite archiving program. Maintain training records utilizing Learning Management System. Provide administrative support to various site departments to help streamline processes for efficiency and effectiveness. Provides logistics support for customer and regulatory audits; meetings; plant meetings & events. May include travel arrangements, meals, lodging, etc… Manage calendars & schedules for Site Lead Team members. Other duties as assigned by the site management team.