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 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 role position: Monday-Friday-Days, 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 happenedPropose CAPAs – how to prevent event from happening in the futureDeploy industry-standard lean and six sigma tools to address the root causes of non-conforming quality eventsFacilitate cross-functional problem-solving eventsAuthor SOPs and work instructionsReview investigation documentation for OOS, OOT or atypical results, as well as deviations from regulations, corporate policy or site proceduresManage timelines for investigations/complaints to ensure that reporting is performed on time and investigations/complaints are addressed in a timely mannerCommunicates clearly with internal and external clients, both verbal and writtenClear understanding of related SOPs and cGMPs as necessary to accomplish daily taskAll other duties as assigned; 

The Candidate 

Required a High School Diploma. Bachelor’s Degree highly desiredRequired a minimum of two years of pharmaceutical packaging and distribution processes, Standard Operating  Procedures (SOPs) and GxPsOne+ year of experience with Technical writing such as validation reports, engineering documents, controlled documents (SOPs, BRs, WIs) in a GxP environment  highly desired.Previous exposure to Lean, Six Sigma, SPC experience preferredDemonstrated ability to motivate and lead others while working alongside them to complete tasks to reach organizational goals highly desiredPossess good communication and problem-solving skills highly desiredWorking knowledge of Microsoft Outlook, Word, Excel, Internet Explorer requiredIndividual may be required to sit, stand, walk regularly and occasionally lift up to 50 poundsOccasional require to work in a Extreme Cold Environment Refrigerator 35°F – 46°F(2°C – 8°C) or a Freezer -4°F (-20°C

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 innovativePotential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 152 hours of PTO + 8 paid holidaysSeveral Employee Resource Groups focusing on D&IDynamic, fast-paced work environmentCommunity 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 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.