Operations Compliance Specialist

Operations Compliance Specialist

Position Summary:

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.

Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture.  The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Services business. Our talented team has over 25 years of experience providing analytical services for stand-alone and integrated biologics projects.

Catalent Pharma Solutions in Kansas City, MO is hiring an Operations Compliance Specialist.  The Operations Compliance Specialist provides technical and regulatory expertise to the investigation and deviation management process to ensure patient safety, regulatory compliance and inspection readiness.

This is a full-time, salaried role.   This is onsite. 

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. 

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
• All other duties as assigned

The Candidate:

• High School Diploma or General Education Diploma is required
• Bachelor’s Degree desired or equivalent experience in the pharmaceutics industry
• At least two years’ knowledge of pharmaceutical packaging and distribution processes, Standard Operating Procedures (SOPs) and GxPs is preferred
• At least one year of technical writing such as validation reports, engineering documents, controlled documents (SOPs, BRs, WIs) in a GxP environment is preferred
• At least one year of Lean, Six Sigma, SPC experience preferred
• Proactive problem-solving and analytical skills
• Individual may be required to sit, stand, walk regularly and occasionally lift up to 40 pounds

Why You Should Join Catalent:

• Defined career path and annual performance review and feedback process 
• Diverse, inclusive culture 
• Positive working environment focusing on continually improving processes to remain innovative
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 
• 152 hours of PTO + 8 paid holidays
• Several Employee Resource Groups focusing on D&I
• Dynamic, fast-paced work environment
• Community engagement and green initiatives 
• Generous 401K match 
• Medical, dental and vision benefits effective day one of employment 
• Tuition Reimbursement - Let us help you finish your degree or start a new degree!
• WellHub- program to promote overall physical wellness 
• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories

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 wit