Document Control Assistant

Document Control Assistant

The Documentation Control Assistant provides document control support to ensure GMP-controlled documents are accurate, compliant, and maintained throughout the document lifecycle. This role works closely with cross-functional teams to support document preparation, revisions, approvals, records management, and archival activities while ensuring compliance with GMP, Good Documentation Practices (GDP), and company quality standards.

Key Responsibilities

• Coordinate the preparation, review, revision, and maintenance of GMP-controlled documents.
• Format, edit, proofread, and manage controlled documents for accuracy and compliance.
• Support document routing, approvals, issuance, distribution, and version control within electronic document management systems (EDMS).
• Maintain document control records and ensure documents are current, properly archived, and readily accessible.
• Track document revisions, change requests, and documentation deadlines.
• Support records management, document retrieval, and archival activities.
• Respond to documentation inquiries and resolve document-related issues.
• Collaborate with cross-functional teams to ensure documentation aligns with company procedures and regulatory requirements.
• Generate document control reports, metrics, and tracking logs.
• Assist with audit and inspection readiness by organizing and retrieving documentation.
• Support continuous improvement initiatives related to document control and records management.
• Perform additional duties as assigned.

Qualifications

Required

• 24 years of experience in document control, records management, quality systems, or administrative support within a GMP-regulated environment.
• Experience creating, formatting, reviewing, and maintaining controlled documents such as SOPs, work instructions, forms, records, and training documents.
• Working knowledge of GMP regulations, Good Documentation Practices (GDP), and document control principles.
• Strong organizational skills with the ability to manage multiple priorities while maintaining a high level of accuracy.
• Proficiency with Microsoft Office (Word, Excel, Outlook) and electronic document management systems (EDMS).
• Excellent attention to detail and commitment to documentation accuracy.

Preferred

• Associate's or Bachelor's degree in Business Administration, Life Sciences, Quality, Technical Writing, or a related field.
• Experience in pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.
• Familiarity with EDMS, Learning Management Systems (LMS), and Quality Management Systems (QMS).
• Experience supporting audits, inspections, records management, and document archival.
• Strong written and verbal communication skills with the ability to work effectively across departments.
• Experience identifying and implementing process improvements.

Work Environment

• Fully onsite position based in Raleigh, NC.
• Standard MondayFriday business hours.
• Primarily office-based with occasional work in manufacturing, laboratory, warehouse, or archival areas.
• Frequent computer use and document review.
• Must be able to occasionally lift up to 25 pounds and comply with applicable GMP and safety requirements.
• No supervisory responsibilities.