Compliance Specialist III
Catalent Pharma Solutions
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.
Job description
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
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
Benefits
- Medical, Dental & Vision
- Paid Time Off
- Paid Holidays
- Tuition Reimbursement
- Career Growth
- Performance Reviews
Company overview
Catalent Pharma Solutions, now known as Catalent, Inc., is a leading global contract development and manufacturing organization (CDMO) headquartered in Tampa, Florida. Founded in 2007 as a spin-off from Cardinal Health's pharmaceutical technologies segment, the company has grown into a major player in the pharmaceutical services industry. Catalent provides comprehensive drug development and manufacturing solutions including drug delivery technologies, formulation development, analytical testing, clinical and commercial manufacturing, clinical packaging, and supply chain services. The company operates over 50 facilities across four continents and has supported more than half of all FDA-approved products over the past decade. With approximately 16,900 employees, Catalent produces over 70 billion doses annually for more than 8,000 products, serving major pharmaceutical companies like Pfizer, Moderna, Novo Nordisk, and Bristol-Myers Squibb. In 2024, the company was acquired by Novo Holdings A/S for $16.5 billion, further strengthening its position in the global pharmaceutical manufacturing landscape.