Mike Werner

Background

About Mike Werner

A results-driven professional with 27 years of experience in document management and a deep understanding of regulatory compliance in fast-paced manufacturing environment. In my role as Manager, Documentation Configuration & Control Specialist, I successfully managed product lifecycle documentation, reviewed company manufacturing documentation for completeness and accuracy, and ensured compliance with stringent FDA and consumer product regulations. By implementing robust version control systems and enhancing the Engineering Change process, I reduced documentation errors and improved accessibility across global teams. My ability to work with tools such as Arena Solutions and SAP has allowed me to support efficient collaboration, maintain process integrity, and uphold high-quality standards essential in manufacturing. Throughout my career, I have honed my ability to assess situations quickly and accurately, employing strong analytical and troubleshooting skills. Working in challenging environments with tight deadlines has refined my capacity to manage multiple priorities simultaneously. Collaborating with cross-functional teams and engaging with all levels of management has strengthened my people skills, enabling me to navigate complex projects effectively.