Documentation Control Assistant

Location: Raleigh, NC
Schedule: Fully Onsite | Monday–Friday | Normal Business Hours
Salary: $50,000–$65,000

Position Summary

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

• 2–4 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 Monday–Friday 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.