About this opportunity
Technical Source lists this Document Control Specialist opportunity in lee county, North Carolina. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Technical Source is looking for a Document Turnover Specialist supporting Electronic Turnover Package (ETOP) completion for a greenfield pharmaceutical manufacturing facility south of Raleigh, NC. The role focuses on reviewing, validating, and coordinating comprehensive turnover documentation across utilities, processing equipment, and laboratory systems. The specialist ensures all packages meet regulatory compliance standards and are complete before facility handoff.
Key Responsibilities
Review incoming ETOP packages for completeness, accuracy, and regulatory compliance
Identify missing or incomplete documentation and coordinate with design engineers, process engineers, vendors, and subcontractors to obtain required materials
Verify all required approvals and sign-offs are in place before package closure
Track outstanding documentation items using ACC system and Excel-based status reports
File completed packages in appropriate directories within ACC documentation system
Communicate clearly with cross-functional teams to drive documentation workflow and resolve blockers
Perform final quality checks to ensure all documentation requirements are met before handoff
Required Qualifications
3–7 years in pharmaceutical manufacturing or GMP/GDP regulated environments
Demonstrated experience with at least one of the following:
Document control in pharmaceutical manufacturing
Turnover package management or ETOP coordination
Commissioning or start-up support for manufacturing equipment
Early-stage project engineering with documentation responsibilities
Understanding of pharmaceutical equipment types and GMP documentation standards
Self-sufficient and proactive work style; ability to work independently with minimal supervision
Strong written and verbal communication skills
Proficient with ACC (or similar document management system), Microsoft Excel, Word, and Outlook
High school diploma or equivalent; 2-year degree or higher preferred
Preferred Qualifications
Prior experience with ACC system
Familiarity with bioreactors, processing equipment, and utility systems in pharmaceutical settings
Commissioning or project engineering background
Bachelor's degree in Engineering, Sciences, or Quality
Experience building relationships and coordinating across multiple stakeholder groups
Knowledge of FDA, ICH, or EMA documentation requirements
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.