Document Control Coordinator I (1st shift)

This position is a member of the Document Control Group, 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.

Responsibilities

• Participate in all aspects of the Document Control Process, including editing, reviewing, tracking, issuing, scanning, and filing of controlled documentation as per applicable Standard Operating Procedures.
• Revise and maintain controlled documents such as Standard Operating Procedures, specifications, protocols, and other miscellaneous documents within the Electronic Document Management System (EDMS).
• Prepare controlled documents through the EDMS and change control process, including editing, proofreading, tracking, printing, scanning, and filing.
• Issue Master Batch Records to production in accordance with SOPs.
• Provide support for regulatory inspections and partner audits.
• Support internal departments by requesting 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.
• Perform tasks with minimal error rate.
• Provide training support regarding the EDMS for internal departments.
• Assist in Central Archive document intake, retrieval, and maintenance.
• Perform any other tasks/duties as assigned by management.

Requirements

• High School Diploma or GED equivalent required; Associates or Bachelor’s Degree preferred.
• 0-1 year experience in Quality Assurance or Document Control function is preferred.
• Minimum 2 years work experience in an FDA regulated environment is preferred.
• Ability to 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).
• Ability to take feedback constructively and function in a team-oriented work environment.
• Ability to work overtime as needed.

Skills

• Document control and management within an EDMS.
• Editing, proofreading, and tracking controlled documents.
• Supporting regulatory inspections and audits.
• Training support for internal departments on EDMS.

Physical Requirements

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