Compliance Specialist III

Catalent Pharma Solutions; Kansas City (MO); On-site; USD 39,000 - 55,000; Full time

Benefits offered by this job

Competitive PTO + 8 paid holidays

Medical, dental, and vision from day 1

Tuition reimbursement

Job summary

Catalent is seeking a Compliance Specialist III in Kansas City, MO to lead investigations and drive compliance improvements in cGMP operations. You will work with cross-functional teams, review technical reports, and maintain rigorous documentation to meet regulatory standards.

The role requires strong attention to detail, experience in regulated industries, and proficiency with Word/Excel. Shift is Monday–Friday, 1pm–9pm, with competitive benefits.

Qualifications

• Bachelor's Degree or equivalent in a regulated industry; OR High School degree with 5+ years in a regulated industry.
• Strong computer skills; proficiency in Word and Excel.
• Well organized with ability to multitask and meet deadlines with strong attention to detail.

Responsibilities

• Lead deviation and investigations using root cause methods (Fishbone, 5-Why).
• Lead cross-functional teams and meetings to address compliance gaps.
• 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 SOPs.
• Assist in writing SOPs for equipment used by operations personnel.
• Maintain high-quality manufacturing documentation per regulatory guidance and SOPs.
• Participate in assigned improvement projects.
• Maintain compliance with all training requirements.
• Perform other duties and special projects as assigned.

Skills

Attention to detail

Multitasking

Regulatory compliance

Education

Bachelor's Degree or equivalent

High School + 5+ years regulated industry

Tools

Fishbone diagrams

5-Why analysis

Root cause analysis

Microsoft Word

Microsoft Excel

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

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

Benefits

• Competitive paid time off plus 8 paid holidays
• Medical, dental, and vision benefits effective day one of employment
• Tuition reimbursement

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

Company Culture and Employer Brand

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.

Equal Opportunity Employer

Catalent is an Equal Opportunity Employer, including disability and veterans.

Company Overview

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.