Document Control, Senior Specialist

Role: Senior Document Control Specialist supporting quality systems within a biopharma environment, ensuring controlled documentation compliance. Responsibilities: administer and oversee global document control processes for GxP records using electronic systems like TrackWise Digital, support document lifecycle management, process improvements, audits, and training; troubleshoot workflow issues; assist with document migration and paper-to-electronic transitions; ensure regulatory compliance and record retention. Requirements: BS/BA with 8-10+ years in quality discipline; 5+ years in Document Control within pharmaceutical, medical device, or biotech sectors; experience with eQMS platforms (e.g., TrackWise Digital, Veeva, MasterControl); strong knowledge of GxP documentation, record retention, and regulatory audit support; proficient in technical writing and MS Office. Preferred: project management, effective communication, attention to detail, ability to work independently. High-Value: supporting GxP controlled documentation, multi-site/global document control programs, GMP compliance, and supporting inspections. Work Setup: on-site in Bedford, MA, 3 days/week; open to US-based applicants.