Specialist I - Quality Assurance Operations, Compliance

Execute internal audits by coordinating with subject matter experts, performing system assessments, and communicating findings to stakeholders. Support customer audits by hosting sessions, providing accurate quality system information, and overseeing response follow-ups. Maintain facility licenses, organize documentation for regulatory submissions, and monitor changes to regulatory guidance. Author Standard Operating Procedures, manage change control and corrective actions, and oversee customer Quality Agreements. Draft technical plans, protocols, and reports for process validation while maintaining statistical tools for system monitoring.