Quality Specialist, Deviations & CAPAs

The Quality Specialist is responsible for ensuring that Deviations (Devs) and Corrective and Preventative Actions (CAPAs) are completed in accurate and timely fashion and are managed in compliance with global regulations, legislation and company requirements.

• Lead the administration, tracking and management of Devs and CAPAs
• Support Subject Matter Experts to conduct root cause analysis or Devs and CAPAs
• Lead Devs and CAPAs through the workflow
• Provide support to operations and act as subject matter expert on process of managing Devs and CAPAs
• May participate in audits and inspections to act as a Dev and CAPA subject matter expert
• May support team management, Dev and CAPA team for periodic trending of deviations data across the company
• Preparing metrics on procedures and trainings for internal Quality and Compliance reporting