About this role
Job title: 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.
Position Summary
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.
Shift: Monday - Friday, 1pm - 9pm, Hourly Location: Kansas City, MO 100% Onsite
The Role
- 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
The Candidate
Minimum Requirements
- 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
Why You Should Join Catalent
- 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
- Competitive paid time off plus 8 paid holidays
- Community engagement and green initiatives
- Medical, dental, and vision benefits effective day one of employment
- Tuition reimbursement
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.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.