Job Description
Summary
The Staff QA Analyst is a recognized Subject Matter Expert (SME) for CAPA, Nonconformance, Complaint Handling, and Health Hazard Assessment (HHA) within the Quality Management System (QMS). Operating with a high degree of autonomy and professional judgment, this role not only leads complex investigations but also serves as a CAPA and HHA Coach, strengthening investigation quality, risk‑based thinking, and regulatory robustness across the QA analyst community. This role influences quality outcomes beyond individual tasks, drives systemic improvement through data‑driven insights, and builds organizational capability through structured coaching and governance—without formal people management responsibility.
Essential Duties and Responsibilities
CAPA Leadership & Coaching (Senior‑Level Differentiator)
- Act as CAPA SME and Coach, providing hands‑on guidance to junior QA Analysts on:
- Clear problem statements and issue framing