Compliance Specialist III

Socket.dev; Kansas; On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Paid time off

8 holidays off

Benefits from day one

Tuition reimbursement

Job summary

Catalent’s Kansas City facility is seeking a Compliance Specialist III to lead investigations and compliance activities, ensuring adherence to regulatory standards. The role requires collaboration with cross-functional teams to identify and resolve gaps, and to maintain high-quality documentation and processes.

This is a 100% onsite position in Kansas City, MO, with a Monday–Friday 1pm–9pm shift. Responsibilities include leading deviations, monitoring trends, reviewing technical reports, and

Qualifications

• Lead investigations and compliance activities to ensure adherence to regulatory standards.
• Strong attention to detail and high-quality documentation.
• Proficient with root cause analysis and cross-functional collaboration.

Responsibilities

• Lead deviation investigations using Fishbone diagrams, 5-Why's and other root cause methods.
• Lead cross-functional meetings to address compliance gaps.
• Monitor compliance trends and identify gaps.
• Assist with review of technical reports supporting cGMP operations.
• Maintain manufacturing documentation per SOPs and regulatory guidance.

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.

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.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

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