Compliance Specialist III

About the role

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. Location: Kansas City, MO 100% Onsite.

Schedule

Shift: Monday - Friday, 1pm - 9pm, Hourly.

Responsibilities

• 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

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

• Defined career path and annual performance review and feedback process
• Diverse, inclusive