Alexandra Rowles Email & Phone Number

• Continuously observe and review aseptic practices on the manufacturing floor as applicable to each manufacturing suite. • Provide immediate feedback during routine observation to develop and improve colleague techniques & capabilities. • Observe and identify opportunities related to aseptic processing microbiological science, microbiological control strategies, the environmental monitoring program and how each impact aseptic manufacturing processes. • Implement projects to improve aseptic process compliance to support effective and compliant process operations. • Evaluate aseptic processes during air flow visualization studies. • Act as an active quality observation area lead while observing aseptic technique and operations during media fill simulations. • Maintain and update proper documentation – SOPs, training records, batch records, check sheets, logbooks, etc. • Act as an active member of investigational activities as it relates to environmental & behavioral compliance events.

● Performed inspection readiness walk-throughs, line clearances, in-process batch record reviews,quarantine/rejection of material, and verifications in support of manufacturing activities● Performed in-process review of production batch records for accuracy of documented entries and conformanceto established procedures in compliance with FDA, EMA, and other cGMP regulations● Generated daily shift reports and communicated non-conformances found during aseptic processing operationsto the QA and Production Supervisor/Manager on shift● Trained quality assurance colleagues and comprehended aseptic techniques and behaviors required in the APA● Lead monthly In Process Batch Record Review and ensured adequate coverage for production areas

Brentwood, Missouri, United States

• Performed inspection readiness walk-throughs, line clearances, in-process batch record reviews, personnel monitoring, quarantine/rejection of material, and verifications in support of manufacturing activities • Communicated non-conformances found during aseptic processing operations to the QA Supervisor/Manager on shift• Performed in-process review of production batch records for accuracy of documented entries and conformance to established procedures• Floor QA point of contact to MQA and Production Management; Serve as QA approver for minor deviations