ETOP Documentation Specialist

Technical Source; North Carolina; On-site; USD 65,000 - 90,000; Full time

Job summary

Technical Source is hiring a Document Turnover Specialist to support ETOP completion for a greenfield pharmaceutical facility south of Raleigh, NC. You will review, validate, and coordinate turnover documentation across utilities, processing equipment, and laboratory systems to ensure regulatory compliance before handoff.

On-site role requiring 3–7 years in GMP environments, experience with ACC and MS Office, and strong cross-functional communication.

Qualifications

• 3–7 years in pharmaceutical manufacturing or GMP/GDP environments.
• Experience in document control, turnover package management, or ETOP coordination.
• Independent worker with proactive communication and problem-solving.
• Proficient with ACC or similar document management system and MS Office.

Responsibilities

• Review ETOP packages for completeness, accuracy, and regulatory compliance.
• Identify missing documentation and coordinate with design/process engineers, vendors, and subcontractors.
• Verify approvals and sign-offs before package closure.
• Track outstanding items using ACC and Excel-based reports.
• File completed packages in ACC directories and maintain organized archives.
• Communicate with cross-functional teams to drive workflow and resolve blockers.
• Perform final quality checks to ensure regulatory requirements are met before handoff.

Skills

Document control

ETOP coordination

Commissioning/start-up

Independent worker

Strong communication

Cross-functional collaboration

Microsoft Excel

Microsoft Word

Microsoft Outlook

Education

High school diploma

2-year degree or higher

Bachelor's degree preferred

Tools

ACC system

Job description

Technical Source is hiring a Document Turnover Specialist to support ETOP completion for a greenfield pharmaceutical facility south of Raleigh, NC. You will review, validate, and coordinate turnover documentation across utilities, processing equipment, and laboratory systems to ensure regulatory compliance before handoff.

On-site role requiring 3–7 years in GMP environments, experience with ACC and MS Office, and strong cross-functional communication.