Specialist I - Quality Assurance Systems, Deviations/CAPAs

Manage complex deviations and Out-of-Specification investigations while overseeing CAPA management systems and internal/external audits. Implement and maintain quality systems, including documentation control, site-wide training, and project review actions to ensure FDA and internal compliance. Drive cross-functional improvement initiatives to enhance processes, procedures, and training for Deviation, OOS, and CAPA workflows. Provide technical assistance and reporting metrics to support regulatory requirements and process optimization.