Label Process Specialist

Position Summary: We have an opportunity for a Label Process Specialist to join our team. This position is responsible for generating and managing the entire label process from the Project Management team, ensuring on-time and accurate delivery of labels for all business unit label requirements. The role involves preparing, coordinating, designing, and generating clinical study and commercial labels, as well as managing kit lists and label printing activities. The successful candidate will work closely with project management and suppliers to ensure compliance with all regulatory and quality standards.

Shift: 8am-4:30pm M-F Location: Kansas City, MO 100% OnsiteThe RoleSet up labeling study requirements using the Label Management Software. Generate kit lists for clinical trial protocols that meet client study and distribution requirements. Import client-provided kit lists into the Label Management Software for accurate and complete records of kit numbers utilized by packaging configurations in the Global Scan Assembly system (GSA).Create label print requests against approved kit list and label design closely with project management to ensure accurate timelines and labeling requirements. Generate and revise label proofs for client review and approval. Provide suggested label text layouts to meet client study needs. Approve label designs and perform peer reviews. Generate multi-language labels using appropriate labeling systems and regulatory references. Coordinate with suppliers for the design and production of multi-page labels (booklet labels).Clean, maintain, calibrate, and adjust printer settings; operate label printers and verify barcodes. Troubleshoot printer issues and manage vendor escalations and and maintain label inventory in conjunction with Supply Chain personnel. Verify PS/PR scope documents for accuracy and required approvals. Participate in project kick-off meetings to establish clinical trial design and label requirements. Manage and maintain logbooks for label design activities. Set up routers, create master bills of materials, and generate work orders for label printing. Allocate label lots to pick lists and manage label stock inventory based on client other duties as assigned. The Candidate

Minimum Requirements: High School Diploma or General Educational Development (GED).Ability to communicate effectively with engineers, technicians, customers, staff, and other personnel. Ability to troubleshoot simple to complex process and equipment problems. Demonstrated ability to plan and independently implement multiple projects. Strong problem-solving and analytical skills. Excellent written, verbal, and interpersonal communication skills, including the ability to present knowledge and analysis with logic, active listening, and a continuing interest in simplification. Act ethically. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Willingness to share skills and information with others. Ability to read, write, and speak clear English. This role also requires 20/30 corrected vision exam and a colorblindness test.

Preferred Skills & Background: Associate degree in business, Graphic Design, or a related field preferred.2–4 years of clinical labeling or related pharmaceutical operations experience preferred. Strong computer and technical experience preferred. Proficiency in business computer applications such as word processing, spreadsheets, and database software preferred.

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, 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.