JT392 - SR ENGINEER

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team.

In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities: Lead and manage change control activities related to manufacturing process changes, ensuring compliance with quality and regulatory requirements.

Support major and trend deviation investigations throughout the full investigation lifecycle, including Root Cause Analysis (RCA), identification and implementation of Corrective and Preventive Actions (CAPA), authoring investigation reports, and presenting findings during regulatory inspections.

Participate in Risk Assessment activities and perform microbial impact assessments to support manufacturing operations and process changes.

Lead ...