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Michael P_edited.jpg

Michael Paeltz


Michael is a servant leader with a proven track record in FDA defense.  As a dynamic, enthusiastic, and positive influence, Michael is seasoned at dealing with stressful situations while remaining calm under pressure.  As a leader in the QC/ QA realm, he has demonstrated success in addressing process gaps, strategizing improvements, and developing solutions to complex challenges.  In addition to strong technical expertise in the QC arena, Michael is a strong project manager with experience in QC Lab Readiness, EMPQ execution, and start-up, validation, and readiness execution for QC Labs.


  • Excels in working with customers and colleagues to understand each of their goals, challenges, concerns, and expectations in order to drive QC Lab Readiness projects.

  • Strong working knowledge of cGMPs and regulatory guidance including US and EU.

  • Experience in leading training, mentoring, and QA/QC  Readiness activities

  • Experience with LIMS integration.

  • Oversaw environmental action level reports and investigations as well as trend reports including tracking effectiveness of preventative actions

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