Minimum of Bachelor's Degree in Science, or related. Minimum of 5 to 7 years' experience in a Pharmaceutical Manufacturing facility working in operations, production, or quality, and a minimum of 3 years' experience in investigation writing in the Pharmaceutical industry.
• Knowledge and understanding of Pharmaceutical GxPs and excellent cGMP documentation skills
• Experience authoring investigations cover Out-of-Specification (OOS) results, Out-of-Tolerance (OOT) results, Media Fill failures, Manufacturing deviations, etc.
• Ability to conduct in-depth interviews and gather pertinent information to drive to root cause conclusions and initiations of CAPA actions, if required
• Exceptional writing and communication skills to clearly convey investigational findings
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.