Description

Summary of Responsibilities:<ul><li>Works with internal teams to progress quality issues in QMS.</li><li>Tracks timeliness of cases in QMS.</li><li>Supports teams in creation of CAPAs.</li><li>Maintains strong working knowledge of QMS.</li><li>Interacts with QA Lead Manager and above as required for quality issue case progression and client notifications.</li><li>Supports QA Lead Manager and above in pulling metric data, trending, and tracking of QI.</li><li>All other duties as needed or assigned.</li></ul>Qualifications (Minimum Required):<ul><li>A minimum of a bachelor’s degree in Life Sciences preferred (or equivalent Life Science experience).</li></ul>Experience (Minimum Required):<ul><li>8 years in regulatory environment (experience in GXP roles).</li><li>Strong understanding of QMS and CAPA process.</li><li>Ability to work well within a team environment.</li><li>Convey key details of quality issues internally.</li><li>Communicate quality issue summary to clients where applicable.</li><li>Knowledge of GCPs/GXPs.</li></ul>Preferred Qualifications Include:<ul><li>Fortrea may consider relevant and equivalent experience in lieu of educational requirements.</li></ul>Physical Demands/Work Environment:<ul><li>Travel may be required.</li><li>Office-Based (Hybrid), as requested by the line manager.</li></ul>Learn more about our <a href="https://careers.fortrea.com/us/en/eeo-and-accommodations" target="_blank">EEO & Accommodations request here</a>.