Document Control Analyst

Role: Document Control Analyst responsible for managing and maintaining the electronic Quality Management System (eQMS) within a regulated biopharma environment. Objectives include ensuring compliance with global regulatory standards and supporting quality, regulatory, laboratory, and manufacturing operations through effective document lifecycle management. Core responsibilities involve document creation, revision, approval, distribution, archiving, audit preparation, and process improvement. The position requires collaboration with cross-functional teams such as QA, Regulatory Affairs, and Manufacturing. Qualifications: 1-3 years’ experience in document control or quality systems in regulated settings; BS/BA in a science-related field or equivalent; proficiency with eQMS and Microsoft Office; strong organizational, communication, and attention to detail skills. Preferred attributes include familiarity with FDA, CAP/CLIA, EU regulations, ISO standards, and experience in process improvement initiatives. High-value specifics include working within an FDA-regulated environment, supporting compliance with GxP standards, and preparing for audits and inspections. The role involves physical activity (lifting up to 30 lbs) and may require weekend/holiday work. Location and travel details are not specified, but the focus is on supporting compliance and operational excellence in document management.