Change Control Analyst

Role: Change Control Analyst responsible for managing the change control process within the eQMS to ensure compliance with regulatory and quality standards. Responsibilities: oversee the lifecycle of change records from initiation through closure, facilitate impact assessments with SMEs, monitor progress, support governance meetings, verify documentation, generate metrics, prepare audit materials, and collaborate across quality, regulatory, manufacturing, and laboratory teams. Requirements: 1-3 years in Quality Systems, QA, Regulatory, or related regulated environments; BS/BA in Life Sciences, Quality, Engineering, or equivalent experience; proficiency with eQMS platforms and MS Office; strong organizational, communication, and record-keeping skills. Preferred qualifications include experience with platforms like Veeva or TrackWise, knowledge of FDA 21 CFR Part 820, ISO standards, validation processes, and supporting regulatory inspections. HighValue: experience in regulated life sciences environments, familiarity with quality system principles, change management, risk assessments, and audit support. WorkSetup: primarily desk-based with occasional exposure to lab/facility environments; potential requirement for weekend or holiday work.