Compliance Specialist III

About Site

Catalent's Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses.

We have an opportunity for a Compliance Specialist III to join our team. In this role, you will lead investigations and compliance activities to ensure adherence to regulatory standards. You will work closely with cross-functional teams to identify and resolve compliance gaps. This position requires strong attention to detail and a commitment to maintaining high-quality documentation and processes.

Monday - Friday, 1pm - 9pm, Hourly

Kansas City, MO

• Lead deviation and investigations using tools such as Fishbone diagrams, 5-Why's, and other root cause analysis methods
• Lead cross-functional teams and meetings to address compliance gaps or concerns
• Monitor compliance trends and identify gaps
• Assist with review of technical reports supporting cGMP operations
• Collaborate with cGMP business units to resolve record inconsistencies
• Recommend batch record changes for continuous improvement per approved Standard Equipment Procedures and Standard Operating Procedures
• Assist in writing Standard Equipment Procedures and Standard Instrument Procedures for equipment and instruments used by pharmaceutics and operations personnel
• Maintain high-quality manufacturing documentation in accordance with regulatory guidance and site Standard Operating Procedures
• Participate in assigned improvement projects
• Maintain compliance with all assigned training requirements
• Perform other duties and special projects as assigned

• Bachelor's Degree or equivalent years of experience in a regulated industry; OR High School degree with 5+ years of experience in a regulated industry
• Strong computer skills and proficiency in Microsoft Word and Microsoft Excel
• Well organized with ability to multitask, work effectively under pressure to meet deadlines, and strong attention to detail

• Competitive paid time off plus 8 paid holidays
• Medical, dental, and vision benefits effective day one of employment
• Tuition reimbursement

Defined career path and annual performance review and feedback process

Diverse, inclusive culture

Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.

Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work.

Catalent is an Equal Opportunity Employer, including disability and veterans.

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year.

Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.