Qualified individuals will be responsible for the design, implementation, and maintenance of the Quality Assurance Documentation and Change Management. Responsibility for issuance, tracking, and control of Standard Operating Procedures, Master Batch Records, Test Records, Forms, Protocols, Amendments, and Final Reports including formatting, editing, and revisions. Serve as administrator current and future quality documentation systems and or software systems. Individual will assist the QS Manager in maintaining a complete Quality Management System (QMS) in compliance to cGMPs.