Documentation Specialist

Spectraforce Technologies

Dec 12, 2025
Position Title: Documentation Specialist Location: Branchburg, NJ 08876 Duration: 6 months (possible extension based on performance and business needs) Work Arrangement: Fully Onsite Position Summary: The Documentation Specialist supports the Document Control team responsible for managing controlled documentation and change requests within a regulated manufacturing environment. This role involves end-to-end document lifecycle management-from creation and review through routing, approval, and release-ensuring compliance with current regulatory and quality requirements. The position focuses on proofreading, document formatting, and control activities within the electronic document management system (eDMS), such as Veeva Vault. Key Responsibilities: Manage controlled documents and document change requests, ensuring compliance with company quality and regulatory standards. Review, proofread, and route controlled documents including SOPs, specifications, forms, policies, and manufacturing documentation within the eDMS. Coordinate document routing and approval workflows with document authors, reviewers, and approvers. Ensure proper approvals are obtained and effective dates are coordinated prior to document release. Support the preparation and issuance of manufacturing documentation to production. Maintain document templates, version control practices, audit trails, and reference archives in alignment with internal procedures. Track and coordinate periodic document reviews and associated actions. Collaborate cross-functionally with QA, operations, and manufacturing teams to address document-related needs. Work independently and as part of a small team, completing assignments and special projects with minimal supervision. Qualifications & Experience: Education: Bachelor's degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or related technical/scientific field preferred. Associate degree candidates with 5+ years of regulated industry experience will be considered. Equivalent regulated industry experience may substitute for a degree. Experience: 3-4 years of document control experience within a regulated environment (pharmaceutical, biotechnology, or medical device preferred). Manufacturing documentation experience strongly preferred. Broader QA document control experience acceptable with strong attention to detail. Hands-on experience with eDMS systems required; Veeva Vault experience strongly preferred. Excellent proofreading and document formatting skills. Proficiency in Microsoft Word and Excel. Strong written and verbal communication skills. Proven ability to manage multiple priorities and complete tasks accurately within deadlines. Strong interpersonal skills and ability to collaborate effectively across departments.