Documentation Specialist

Spectraforce Technologies
United States, California, Irvine
Apr 08, 2025
Job Title: Documentation Specialist Location: Irvine, CA Duration: 6-month contract (No guarantee of extension) Schedule: Monday - Friday, 8:00 AM - 4:30 PM Overview: This position supports the Tech Transfer group and is responsible for maintaining and facilitating the updating and routing of controlled documents within the electronic document management system (OneVault). Documents include, but are not limited to, Governance and Procedure documents, Master Forms, and Master Batch Records. Key Responsibilities: Facilitate the updating and routing of controlled documents such as SOPs, Master Batch Records, and Protocols using OneVault. Support document formatting and drafting in collaboration with subject matter experts (SMEs). Ensure timely retrieval of document requests for internal, external, and regulatory audits. Participate in team meetings and departmental training sessions. Provide input for process improvements and assist with achieving team and departmental goals. Ensure compliance with environmental, health, and safety standards. Top Skills & Requirements: Technical Writing / Documentation: Experience with SOPs, batch records, and protocols. Documentation review and record management experience (preferred). Software Proficiency: Microsoft Word (Most Important) Microsoft Excel Experience with OneVault, SAP, or other document management systems (preferred). General Qualifications: Excellent proofreading, verbal, and written communication skills. Strong analytical and problem-solving abilities. Experience in regulated environments and understanding of cGMPs. Familiarity with Quality Assurance systems. Education & Experience: Preferred: Bachelor's Degree + 1 year of related experience Minimum: High School Diploma or GED + 3 years of relevant experience Industry Experience: Pharmaceutical or document management experience strongly preferred