Documentation Control Specialist

Job Summary: The Documentation Control Specialist is responsible for developing, producing, and maintaining a variety of complex technical and user documentation. This role requires planning and executing writing projects that involve intricate technical content while ensuring effective presentation and timely reporting on progress in meeting schedule milestones. Key Responsibilities: Documentation Development: Create, edit, and maintain technical documentation, ensuring clarity and consistency in explaining complex information simply and accurately. Project Management: Determine project requirements and manage writing, copy editing, technical editing, and documentation design activities. Document Control: Oversee the control of the Quality Management System (QMS) and GMP-critical documentation, ensuring that reviews and approvals are conducted efficiently. Record Maintenance: Maintain meticulous records of document status, outstanding change controls, reviews, and approvals. Template Compliance: Ensure that all documents adhere to established templates, formats, and naming conventions. Electronic Document Library Management: Maintain the electronic document library and develop/maintain a QMS document inventory that includes identification, status, effective dates, and other pertinent information. Quality Records Management: Manage and control specific quality records as required and distribute controlled documentation to points of use. Document Requests Processing: Process requests for copies of controlled documents and quality records. Qualifications: Education: Bachelor's degree and 3-5 years of experience in a relevant field, or equivalent experience. GMP Experience: Experience in a GMP-controlled environment, with knowledge of document control strategies or methods. Technical Skills: Proficiency in MS Office products and the ability to learn new systems as needed. Communication: Strong communication skills in English, both oral and written. Software Proficiency: Prior experience with word processing, spreadsheet, and presentation software. Essential Functions: Distribute controlled documents (procedures, specifications) to the production floor and other points of use. Sort, file, and maintain controlled documents and other quality records (e.g., TRVs, DHRs) in the Document Control room. Coordinate off-site storage activities when necessary. Assist in organizing and maintaining efficient documentation processes. Qualifications/Requirements: High school diploma with a minimum of 3 years of experience in a GMP-controlled environment, or an associate's degree with at least 2 years in a document control or administrative role. Must be able to lift up to 30 lbs and perform physical tasks (e.g., moving boxes containing documents). Self-starter with the ability to learn quickly and work independently with minimal supervision. Exceptional attention to detail and organizational skills. Strong interpersonal skills and the ability to work effectively in a fast-paced environment, meeting simultaneous deadlines. Ability to collaborate with cross-functional teams and various departments. Education: High School