QA Specialist III
Core
Lead and drive quality assurance projects, investigations, and continuous improvement for digital solutions and manufacturing processes to ensure product quality and regulatory compliance.
Role type
Senior Quality Assurance Specialist (GxP)
Builds
Quality compliant digital solutions and manufacturing processes
Domain
Pharmaceutical manufacturing and Quality Assurance
Required skills
GxP regulations knowledge, GMP manufacturing experience, complex quality issue resolution, CAPA management, SOP authoring and review, change control management, FDA guidelines application, independent project leadership, critical thinking
Preferred skills
Quality administered systems experience, regulatory compliance documentation, mentoring capabilities, AI tool usage (ChatGPT, Copilot)
Technologies
Microsoft Excel, Microsoft Word, Generative AI tools
Responsibilities
Lead/co-lead projects for digital solutions, provide independent quality review and oversight of site documentation, resolve complex quality issues and drive CAPAs, review and approve electronic records, protocols, reports, and SOPs, manage change controls, anticipate issues and provide recommendations
Seniority
Senior, hands-on IC
