Document Control Coordinator

Job Title: Document Control Coordinator

Work Location: Middlesex County, Massachusetts

Summary:

The Document Control Coordinator is responsible for supporting documentation processes, maintaining document systems, and ensuring compliance with regulatory standards for document control and written procedures.

Responsibilities:

• Manage archival, retrieval, and destruction of regulated documents, ensuring compliance with retention policies and approvals.
• Digitize and electronically store documents, maintaining accurate and organized electronic records.
• Create and update document file folders, history files, and binders with proper labeling and location details.
• Monitor and track documentation for periodic review, reconciling forms issued through electronic document management systems.
• Coordinate labeling, scheduling, and inventory of boxes for offsite storage, transferring contents to inventory spreadsheets as needed.
• Perform word processing, data entry, and other organizational tasks to support documentation activities.
• Review and identify quality documentation in storage, ensuring accurate site inventory and adherence to written policies and procedures.
• Adapt to changing priorities, collaborating with team members and performing additional duties as assigned.

Qualifications:

• High School Diploma or GED required; degree preferred.
• 1–2 years of related experience in pharmaceutical, FDA-regulated, or medical device industry preferred.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Access) and working knowledge of Adobe Acrobat.
• Experience with documentation functions in cGMP or ISO-regulated environments.
• Detail-oriented with strong multitasking abilities in a fast-paced setting.
• Effective verbal, written, and interpersonal communication skills.
• Ability to collaborate as a team player and demonstrate flexibility with changing assignments.
• Understanding of regulatory compliance requirements and documentation best practices.

Published Category: Quality & Validation