Specialist, Quality Assurance

Provide real-time, on-the-floor Quality support to Manufacturing through direct observation of activities and monitoring process operations for compliance. Make timely quality decisions while escalating issues impacting operations and proactively identifying risks within GMP processes. Perform routine facility walkthroughs to verify suite readiness, GMP compliance, and support troubleshooting activities. Ensure adherence to cGMP requirements, Standard Operating Procedures, and manufacturing documentation while managing new deviation events and reviewing minor deviations. Coordinate and approve deviation and minor change control records, issue laboratory notebooks, and manage document archival activities. Support Material Release, Batch Record Review, and Product Disposition activities. Monitor quality system metrics and process performance indicators to ensure compliance and operational excellence. Provide Quality oversight of the Contamination Control Strategy, Environmental Monitoring Program, and Facility Sanitization Program. Author, review, and approve quality documentation including SOPs, Work Instructions, Forms, and Training Materials. Champion continuous improvement initiatives through strengthened quality systems and streamlined business processes. Work effectively within a shift structure, including morning, afternoon, and night shifts.