Compliance Specialist II

Compliance Specialist II

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 II to join our team. In this role, you will support cGMP business units to ensure a high level of compliance. You will work under the guidance of a supervisor to ensure all documentation meets regulatory requirements, good manufacturing practices, and standard operating procedures. This position is key to maintaining quality and readiness for client interactions.

Shift: Mon to Fri 8am-5pm Location: Kansas City, MO 100% Onsite

The Role

• Review executed batch records and documentation to ensure conformance to cGMPs, SOPs, and other protocols.
• Draft and review batch records for use by pharmaceutics and operations personnel.
• Recommend batch record changes for continuous improvement per approved SOPs and collaborate with cGMP business units to resolve inconsistencies.
• Draft standard operating procedures for processes used by pharmaceutics and operations personnel.
• Complete all assigned training and follow training guidelines strictly.
• Maintain high-quality manufacturing documentation in accordance with regulatory guidance and site SOPs.
• Maintain readiness for on-site clients.
• Perform spot-checks of experimental areas and assets, and track laboratory notebooks.
• Track and trend batch record initiation, approvals, updates, and feedback after execution.
• Perform all other duties as assigned.

The Candidate

Minimum Requirements

• High School Diploma or General Educational Development (GED) 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 a variety of instructions furnished 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.

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.