Primary role of this position is to author investigations into manufacturing deviations and identify the root cause(s) and appropriate CAPA actions, utilizing appropriate Root Cause Analysis Tools for assigned deviations.
Minimum of Bachelor's Degree in Science or Engineering, or related 5+ years of experience in Pharmaceutical Manufacturing Facility
Key Skills: • Experience in manufacturing / operations / production / quality • Gather pertinent information to supporting investigation reports • Exceptional writing skills and ability to work in a high pressure environment • Previous experience in Pharmaceutical Manufacturing facility either in Quality Engineer / Operation or Quality • Ability to conduct interviews, self-sufficient, diligent worker
About Protocol Link, Inc. Headquartered in Chicago metropolitan area, Protocol Link is a leading project management and strategy consulting firm providing comprehensive regulatory affairs, cGMP compliance, quality assurance, and validation services to the FDA-regulated companies worldwide. Protocol Link’s mission is to provide customer-focused services with ethical conduct, mutual trust, and personnel empowerment while striving to offer the best of both quality and efficiency. It's how we've been doing business since 1996. The right way.