Michael Paeltz

DIRECTOR OF QUALITY CONTROL

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