Compliance Specialist III

Compliance Specialist III position at Catalent's Kansas City facility focusing on leading investigations, monitoring regulatory adherence, and resolving compliance gaps across cGMP operations. The role involves root cause analysis, cross-functional collaboration, and documentation management in pharmaceutical manufacturing.

Responsibilities

• Lead deviation investigations and root cause analysis using analytical tools and methodologies
• Oversee cross-functional meetings to identify and resolve compliance gaps
• Monitor compliance trends and assist with technical report review for cGMP operations
• Develop and maintain Standard Operating Procedures and equipment documentation
• Collaborate with business units to address record inconsistencies and recommend batch record improvements

Requirements

• Bachelor's degree or equivalent regulated industry experience; or high school diploma with 5+ years regulated industry experience
• Proficiency in Microsoft Word and Microsoft Excel
• Strong organizational skills and ability to multitask under pressure
• Meticulous attention to detail in documentation and process management
• Ability to lead cross-functional teams and conduct investigations