Document Control Coordinator II

Nature and Scope

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 group provides support to other departments as needed and is critical in maintaining production schedules and meeting company goals. 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

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

• 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

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• High School Diploma or GED equivalent required. Associates or Bachelor's Degree preferred.

• 1-2-year experience in Quality Assurance or Document Control function is preferred.

• Experience in a pharmaceutical manufacturing environment is preferred.

• Must be able to do work independently, recognizing what needs to be done and accomplishing it with minimal supervision.

• Intermediate skills in Microsoft Word and Excel are required.

• Excellent organizational, interpersonal and communication skills (written and oral) required.

• Ability to take feedback constructively and function in a team-oriented work environment.

• Ability to work overtime as needed.

Physical Environment and Requirements

• Employee must be able to occasionally lift and/or move up to 25 pounds.

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.

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