Document Control Specialist

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