Compliance Specialist III
Catalent
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
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
- 8 Paid Holidays
- Tuition Reimbursement
- Career Growth
- Annual Performance Review
Company overview
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) that serves as a trusted partner to pharmaceutical, biotech, and consumer health companies worldwide. Founded on a legacy dating back to 1933, Catalent has evolved into a comprehensive drug development and delivery leader with over 40 global sites. The company specializes in providing end-to-end solutions spanning oral dose formulations, biologics, specialty products, and clinical supply services. Catalent's expertise includes formulation development, analytical services, commercial manufacturing, and advanced delivery technologies such as Zydis® fast-dissolve tablets and softgel technologies. With over 1,000 active development programs at any given time, the company launches more than 100 new products and line extensions annually and has supported half of all FDA approvals over the past decade. Catalent produces over 60 billion treatment doses per year, helping approximately 200 million patients annually. Headquartered in Tampa, Florida, the company employs more than 10,000 professionals globally who are dedicated to putting patients first and championing the missions that matter in healthcare innovation.