Senior QA Engineer, Sterility Assurance

Position Overview

The Senior QA Engineer, Sterility Assurance is responsible for providing Quality Assurance oversight of the site’s sterility assurance program to ensure the manufacture of sterile pharmaceutical products in compliance with current Good Manufacturing Practices (cGMP), applicable regulatory requirements, and established corporate quality standards. This position leads the development, implementation, maintenance, and continuous improvement of the site’s sterility assurance program, aseptic processing controls, environmental and personnel monitoring programs, and other critical elements of the sterility assurance system, in support of the site’s contamination control strategy (CCS).