Operational Compliance Specialist

Operational Compliance Specialist

Position Summary

• Work Schedule: M-F during regular business hours

• 100% based on-site in Kansas City

Catalent’s Kansas City (KCM) facility is a premier site for integrated drug development, manufacturing, and clinical supply services, supporting a wide range of pharmaceutical and biotech products. With cutting-edge technologies and a collaborative work environment, it offers exciting opportunities for professionals across all functions—from science and engineering to operations and logistics.

The Operational Compliance Specialist provides technical and regulatory expertise to the investigation and deviation management process to ensure patient safety, regulatory compliance and inspection readiness.

The Role

• Participate in and facilitate Rapid Response Team fact gathering

• Write Investigation reports – These written reports will clearly communicate what happened, why it happened, when it happened

• Propose CAPAs – how to prevent event from happening in the future

• Deploy industry-standard lean and six sigma tools to address the root causes of non-conforming quality events

• Facilitate cross-functional problem-solving events

• Author SOPs and work instructions

• Review investigation documentation for OOS, OOT or atypical results, as well as deviations from regulations, corporate policy or site procedures

• Manage timelines for investigations/complaints to ensure that reporting is performed on time and investigations/complaints are addressed in a timely manner

• Communicates clearly with internal and external clients, both verbal and written

• Other duties assigned

The Candidate

• HS Diploma or GED required

• Bachelor’s Degree desired or equivalent experience in the pharmaceutical industry

• Knowledge (minimum of 2 years) of pharmaceutical packaging and distribution processes, Standard Operating Procedures (SOPs) and GxPs

• Technical writing such as validation reports, engineering documents, controlled documents (SOPs, BRs, WIs) in a GxP environment (minimum of 1 year)

• Lean, Six Sigma, SPC experience (1 year preferred)

• Proactive problem-solving and analytical skills

• Self-motivated, disciplined, focused, work well under pressure and be able to prioritize work

• Ability to simultaneously work on several projects with the flexibility to reprioritize in a minimum amount of time

Why you should join Catalent

• Career growth with a clear path and regular performance reviews

• Day-one benefits: medical, dental, vision

• 401(k) match, tuition reimbursement, and wellness perks

• Paid time off: 152 hours + 8 holidays

• Inclusive culture with Employee Resource Groups and community initiatives

• Discounts from 900+ merchants via Perkspot

• A mission-driven workplace where your work helps save lives

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 DisabilityAccommodations@catalent.com. 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 spam@catalent.com for us to investigate with local authorities.

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