Sr. Quality Specialist, GxP Document Control

Position Overview Senior QA Specialist, GxP Document Control and Quality Systems. Hybrid (Boston; three days onsite/week; remote considered). Responsibilities Lead day-to-day document control in the electronic QMS (development, formatting, routing, review/approval, issuance, revision, archival/retirement of controlled SOPs/forms/templates/logs) per company procedures and GxP. Organize, maintain, and archive GxP documentation outside the formal QMS for inspection readiness and easy retrieval. Support the GxP QMS function and partner with GMP Operations & Supplier Management and Clinical GCP Quality. Develop/maintain training curriculum and GxP tracking; support Deviation/CAPA, Change Control, Management Review, and inspection readiness. Support internal/external audit scheduling/logistics; track audit status and assist with follow-up. Build/maintain quality metrics, dashboards, trackers, and trending tools (Smartsheet, Microsoft Excel). Collaborate cross-functionally to improve quality systems and ensure GxP compliance (GCP/GMP). Support additional Quality Systems initiatives as assigned. Qualifications Bachelor’s in a scientific discipline (or equivalent education + relevant experience). 5+ years in Quality Assurance, Quality Systems, or Document Control (biotech/pharma/regulated industry). Experience in GxP environments (GCP and/or GMP). Working knowledge of document control and eQMS. Experience with audits, CAPAs, training management, controlled documentation, inspection readiness, and quality metrics reporting. Proficiency in Microsoft Excel; experience with Smartsheet (or similar). Strong organization, analytical/problem‑solving, attention to detail, and written/verbal communication. Clinical‑stage biotech/pharma experience preferred. Compensation Range $105K–$128K #J-18808-Ljbffr Scorpion Therapeutics