QA Document Specialist

The purpose of this role is to author technical documents to change current processes for drug development. 

 Collect details from cross-functional departments to author change controls for components and raw materialsEnter change controls into electronic system (QTS) and routing to departments for assessmentsTrack and project manage the assessment completionRoute change control for approval, track and manage approvalsTrack task completion associated with approved change control and work with owners to ensure tasks are completed by assigned due datesEnter new enrollment tasks into electronic system (QTS) and assign task ownersExtend enrollment due dates when neededAdhere to site SOPs and cGMPs for production activities in the manufacturing facilitiesAdhere to site safety standards, participate in routine safety training events, and enforce safety and biosafety requirements as they relate to the Clinical Manufacturing department