Compliance Specialist III

Catalent • Kansas City, MO

7d • Onsite

About The Position

Catalent’s Kansas City facility supports Oral & Specialty Drug Delivery, Biologics Analytical Services, and Clinical Supply Services. The Compliance Specialist III supports the preparation, review, and approval of technical and regulatory documentation, ensuring compliance with current Good Manufacturing Practices and internal procedures. The role contributes to high-quality pharmaceutical operations and continuous improvement. It is based 100% onsite in Kansas City, Missouri, Monday through Friday, 8 a.m. to 5 p.m.

Requirements

• Bachelor’s degree, or a high school diploma or equivalent years of experience in a regulated industry.
• Ability to work effectively under pressure and meet deadlines while maintaining attention to detail.
• Ability to multitask and follow varied instructions provided in written, oral, diagram, or schedule form.
• Mathematical and scientific reasoning ability.
• Strong computer skills and proficiency in Microsoft Word and Microsoft Excel.
• Proactive in addressing work issues at the individual level.

Responsibilities

• Author and approve technical documents, including protocols, reports, and operating procedures.
• Review technical documents for accuracy, thoroughness, and regulatory compliance.
• Review executed batch records and documentation for conformance with current Good Manufacturing Practices, Standard Operating Procedures, and other protocols.
• Draft and review batch records for use by pharmaceutics and/or operations personnel.
• Draft Standard Operating Procedures for processes used by pharmaceutics and/or operations personnel.
• Perform spot-checks of experimental areas and assets, and track laboratory notebooks.
• Track and trend batch record initiation, approvals, updates, and feedback after execution.
• Maintain readiness for on-site clients.
• Perform other duties as assigned.

Benefits

• Defined career path and annual performance review and feedback process.
• Diverse, inclusive culture.
• Potential for career growth on an expanding team.
• Competitive paid time off and 8 paid holidays.
• Community engagement and green initiatives.
• Medical, dental, and vision benefits effective on the first day of employment.
• Tuition reimbursement.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level