Compliance Specialist III

Catalent Pharma Solutions; Kansas City (KS); On-site; USD 65,000 - 85,000; Full time

Benefits offered by this job

Career growth

Paid time off

8 holidays

Benefits from day one

Job summary

Catalent is seeking a Compliance Specialist III for its Kansas City facility to lead investigations and ensure adherence to regulatory standards across cGMP operations. You will work with cross-functional teams to identify and resolve compliance gaps, maintaining high-quality documentation.

This full-time, onsite role runs Monday–Friday, 1pm–9pm in Kansas City, MO, with emphasis on deviation management, trend monitoring, and continuous improvement of manufacturing records and procedures.

Qualifications

• Bachelor’s degree or equivalent in a regulated industry, or a high school diploma with 5+ years of related experience.
• Proficiency in Microsoft Word and Excel with strong computer skills.
• Well organized, capable of multitasking and meeting deadlines with attention to detail.

Responsibilities

• Lead deviation and investigations using root cause analysis methods.
• Lead cross-functional teams and meetings to address compliance gaps.
• Monitor compliance trends and identify gaps in processes.
• Assist with review of technical reports supporting cGMP operations.
• Collaborate with cGMP units to resolve record inconsistencies.
• Recommend batch record changes for continuous improvement per SOPs.
• Assist in writing SOPs for equipment and instruments used in operations.
• Maintain high-quality manufacturing documentation per regulatory guidance.
• Participate in assigned improvement projects and training requirements.
• Perform other duties and special projects as assigned.

Skills

Attention to detail

Strong computer skills

MS Word

MS Excel

Education

Bachelor’s Degree or equivalent in a regulated industry

High School diploma with 5+ years in a regulated industry

Job description

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.

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

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.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [e-mail]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.