Document Control Coordinator II

Document Control Coordinator

This position is a member of the Document Control Group. The Document Control Group is responsible for controlled documents associated with the manufacture of safe, pure, effective and sterile pharmaceuticals in accordance with company SOPs, policies and cGMPs. The Document Control Coordinator will participate in all aspects of the Document Control Process. This includes all elements of the document lifecycle such as editing, reviewing, tracking, issuing, scanning and filing of controlled documentation as per applicable Standard Operating Procedures. The Document Control Coordinator works under the direct supervision of the Document Control Supervisor.

Essential Duties and Responsibilities

• Responsible for the editing and maintenance of controlled documents including Standard Operating Procedures, Master Batch Records, Specifications, Protocols, and other miscellaneous documents within the Electronic Document Management System (EDMS).
• Update internal department standard operating procedures and other documents, as needed.
• Issue and review / release Master Batch Records to production in accordance with SOPs.
• Provide support for regulatory inspections and partner audits.
• Responsible for providing support to internal departments by providing controlled copies, updating departments on periodic review, creating / sharing EDMS reports and reassigning tasks, as needed.
• Ensure all work is performed and documented in accordance with cGMP requirements and standard operating procedures.
• Responsible for issuing batch numbers per SOP in response to the released production schedule.
• Perform and conduct internal investigation support when deviations occur.
• Able to perform tasks with minimal error rate.
• Conducts full user access EDMS training to all internal employees.
• Responsible for updating company metrics related to the department.
• Provide guidance and assistance to the Central Archive regarding document intake, retrieval, and maintenance.
• Assist with product support - EDMS testing which includes IQ / PQ for new releases.
• Perform any other tasks / duties as assigned by management.

Education Requirements and Qualifications

Physical Environment and Requirements

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws.