Documentation Specialist

Responsibilities Develop, produce, and maintain complex technical and user documentation. Plan and execute writing projects involving detailed and technical content. Present complex information clearly and effectively, ensuring timely progress reporting against schedule milestones. Utilize advanced word processing tools and software applications. Determine project requirements and perform complex writing, copy editing, technical editing, and documentation design activities. Create document structures and graphics at the project level. Write consistent, clear, and accurate documentation that simplifies complex information. Documentation Control & QMS Responsibilities Manage control of Quality Management System (QMS) and GMP-critical documentation. Coordinate and track document reviews and approvals efficiently. Maintain accurate records of document status, change controls, reviews, and approvals. Ensure documents comply with established templates, formatting, naming, and numbering standards. Verify document cross-references for accuracy and traceability. Maintain electronic document libraries and QMS document inventory, including document identification, status, and effective dates. Manage and control quality records as required. Distribute and retrieve controlled documentation at points of use. Process requests for copies of controlled documents and quality records. Sort, file, and maintain controlled documents and quality records. Coordinate off-site document storage activities when necessary. Qualifications & Skills Bachelor’s degree with 3–5 years of experience, or equivalent experience. Bachelor’s degree or high school diploma with relevant GMP or document control experience. Experience in document control within a GMP-controlled environment. Proficiency in Microsoft Office (Word, Excel, PowerPoint) and ability to learn new systems. Strong writing, editing, and documentation design skills. Excellent organizational skills and attention to detail. Ability to communicate effectively in English (written and verbal). Ability to work independently with minimal supervision. Capable of working in a fast-paced environment and meeting multiple deadlines. Experience collaborating with cross-functional teams and departments. Ability to perform physical tasks, including lifting up to 30 lbs and handling document storage activities. Self-motivated, adaptable, and results-oriented with strong interpersonal skills. #J-18808-Ljbffr