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.

• 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