Document Control Specialist

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.

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Key ResponsibilitiesReview incoming ETOP packages for completeness, accuracy, and regulatory complianceIdentify missing or incomplete documentation and coordinate with design engineers, process engineers, vendors, and subcontractors to obtain required materialsVerify all required approvals and sign-offs are in place before package closureTrack outstanding documentation items using ACC system and Excel-based status reportsFile completed packages in appropriate directories within ACC documentation systemCommunicate clearly with cross-functional teams to drive documentation workflow and resolve blockersPerform final quality checks to ensure all documentation requirements are met before handoff
Required Qualifications3–7 years in pharmaceutical manufacturing or GMP/GDP regulated environmentsDemonstrated experience with at least one of the following:Document control in pharmaceutical manufacturingTurnover package management or ETOP coordinationCommissioning or start-up support for manufacturing equipmentEarly-stage project engineering with documentation responsibilitiesUnderstanding of pharmaceutical equipment types and GMP documentation standardsSelf-sufficient and proactive work style; ability to work independently with minimal supervisionStrong written and verbal communication skills xzbcwsv Proficient with ACC (or similar document management system), Microsoft Excel, Word, and OutlookHigh school diploma or equivalent; 2-year degree or higher preferredPreferred QualificationsPrior experience with ACC systemFamiliarity with bioreactors, processing equipment, and utility systems in pharmaceutical settingsCommissioning or project engineering backgroundBachelor's degree in Engineering, Sciences, or QualityExperience building relationships and coordinating across multiple stakeholder groupsKnowledge of FDA, ICH, or EMA documentation requirements