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Documentation Specialist

Spectraforce Technologies
United States, California, Irvine
Apr 08, 2025
Document Specialist Location: Irvine, CA, 92612 Schedule: Monday - Friday, 8:00 AM - 4:30 PM Assignment Length: 6-month contract (no guarantee of extension) Overview: This role is responsible for maintaining, updating, and routing controlled documents-including Governance and Procedure documents, Master Forms, and Master Batch Records-within the electronic document management system (OneVault). Key Responsibilities: Draft, format, and update controlled documents, including SOPs, Master Batch Records, and Master Forms using Microsoft Word and established templates Collaborate with SMEs to restructure and edit content in alignment with compliance standards Manage document routing through the OneVault electronic document management system, ensuring proper version control and review workflows Support internal, external, and regulatory audits by ensuring timely access to documentation Participate in team meetings, training sessions, and provide input on improving document processes Ensure all documents are compliant with cGMP and Quality Assurance (QA) standards Maintain detailed and accurate records of document changes and lifecycle history No physical lifting or hands-on manufacturing work-this is a documentation-focused position Qualifications & Skills: Bachelor's degree preferred OR High School Diploma/GED with 3+ years of relevant experience Minimum of 1 year of documentation experience, preferably in pharmaceutical or regulated environments Strong proficiency in Microsoft Word is essential; experience with Excel and PowerPoint also required Familiarity with OneVault, SAP, or similar electronic document control systems preferred Experience working with SOPs, protocols, batch records, and structured documentation formatting Excellent proofreading, analytical, and problem-solving skills Ability to quickly learn and adapt to new systems (training on OneVault will be provided if needed) Understanding of Quality Assurance systems and cGMPs is preferred but not mandatory