Compliance Specialist III

Catalent Pharma Solutions; Kansas City (MO); Vor Ort; USD 65.000 - 90.000; Vollzeit

Benefits dieser Stelle

Competitive PTO and holidays

Benefits from day one (medical, dental

Tuition reimbursement

Career growth within an expanding team

Zusammenfassung

Catalent Pharma Solutions in Kansas City is seeking a Compliance Specialist III to lead investigations and drive regulatory compliance improvements. You will partner with cross-functional teams to close gaps and ensure high-quality documentation and processes.

The role requires attention to detail, strong problem-solving, and experience in regulated environments. It is an onsite position with a Monday–Friday 1pm–9pm shift and a focus on cGMP operations.

Qualifikationen

• Bachelor’s degree or equivalent in a regulated industry, or HS diploma with 5+ years in a regulated setting.
• Strong computer skills including Word and Excel; well organized with multitasking ability.
• Attention to detail and ability to work under pressure to meet deadlines.

Aufgaben

• Lead deviation and investigations using Fishbone diagrams, 5-Why’s, and root cause analysis.
• Lead cross-functional teams to address compliance gaps or concerns.
• Monitor compliance trends and identify gaps.
• 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 Standard Equipment Procedures and Standard Instrument Procedures.
• Maintain high-quality manufacturing documentation per regulatory guidance and SOPs.
• Participate in assigned improvement projects and training requirements.
• Perform other duties and special projects as assigned.

Kenntnisse

Microsoft Word

Microsoft Excel

Attention to detail

Multitasking

Ausbildung

Bachelor’s degree or equivalent in a regulated industry

High School degree with 5+ years of regulated industry experience

Tools

Fishbone diagrams

5-Why root cause analysis

Jobbeschreibung

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.

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.

Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond - it is a fraudulent request. Please forward such requests to [e-mail] for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.

Volunteer Work Disclosure: Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis.

Massachusetts Lie Detector Test Notice: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.

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.