Document Controller
- Manatí, PR
- Permanente
- Tiempo completo
- Author, revise, and maintain SOPs and related controlled documents in accordance with regulatory and company standards.
- Collaborate with cross-functional teams (e.g., QA, QC, Manufacturing, R&D, Regulatory) to gather process information and ensure SOPs reflect current practices.
- Ensure SOPs are clear, concise, and user-friendly, enabling consistent execution by staff.
- Manage document lifecycle using electronic document management systems (EDMS), including version control, approvals, and archival.
- Support internal and external audits by ensuring documentation is inspection-ready.
- Train staff on new or revised SOPs and maintain training records.
- Continuously improve documentation practices to enhance clarity, compliance, and usability.
- Education: Bachelor’s degree in Life Sciences, Engineering, Technical Writing, or related field.
- Experience: 2–5 years in a regulated industry (pharma, biotech, medical devices) with direct experience in SOP writing or quality documentation.
- Knowledge of regulations such as FDA 21 CFR Part 11, ISO 13485, ICH Q10, and GxP principles.
- Proficiency in EDMS (e.g., Veeva, CDOCS, Kneat, AML, MasterControl, Documentum).
- Strong writing and editing skills, with the ability to translate complex processes into clear instructions.
- Attention to detail and strong organizational skills.
- Excellent communication and interpersonal skills for cross-functio