Document Control Specialist

Open to current students/recent graduates! 

Gain experience in the biotechnology industry.

The Document Control Specialist (internship) will support the relocation and organization of our GMP archive room. This role will focus on cataloging, verifying, scanning, and properly filing controlled documentation in accordance with established procedures and compliance expectations. The ideal candidate is detail‑oriented, organized, and comfortable working with both physical and electronic records. 

• Catalog GMP documentation within Excel spreadsheets, ensuring accuracy and completeness. 
• Identify and verify scan status of records within designated shared drive pathways. 
• Scan, upload, and file documents into appropriate electronic folders following established naming and storage conventions. 
• Organize physical records into appropriate storage categories (e.g., binders, boxes, long‑term archive containers). 
• Prepare, sort, label, and consolidate documents prior to relocation. 
• Relocate large volumes of documentation from the existing archive room to the designated new storage area. 
• Maintain good documentation practices (GDP) while handling all records. 
• Assist with general archive room organization, inventorying, and cleanup as needed. 
• Follow all safety, quality, and data integrity expectations during document handling. 
• Understanding of cGMP, 21 CFR 210/211 and other regulatory agency requirements which apply to quality operations and compliance 
• Conduct business in a responsible manner that complies with all state, OSHA and Federal regulations 
• Understanding of FDA, EU, and other regulatory agency requirements 

Requirements: 

• Experience handling and organizing GMP documentation (preferred)
• Knowledge of quality assurance (QA), GMP documentation, and basic compliance principles. 
• Strong attention to detail and commitment to accuracy. 
• Highly organized with the ability to prioritize and manage repetitive tasks. 
• Proficiency in Microsoft Office, especially Excel, and overall computer literacy. 
• Experience scanning and managing large volumes of documents.
• Ability to work independently and follow established procedures. 
• Strong communication skills and ability to ask clarifying questions when needed. 
• Ability to sit for prolonged periods while cataloging or performing data entry. 
• Ability to stand for prolonged periods during scanning or document sorting. 
• Ability to lift, move, and carry boxes or stacks of documentation (up to 25 lbs). 
• Comfortable with repetitive motion tasks (e.g., sorting, scanning, filing).