Onsite Label Process Specialist — Labeling & Compliance

catalent; Kansas City (MO); On-site; USD 45,000 - 70,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

Tuition reimbursement

Paid time off and holidays

Onsite career growth opportunities

Job summary

Catalent’s Kansas City facility is seeking a Label Process Specialist to manage the entire label process from project management through printing and verification. The role involves preparing, coordinating, and generating clinical study and commercial labels, maintaining kit lists, and ensuring regulatory compliance.

The position is 100% onsite in Kansas City, MO. The candidate will work with project management and suppliers to ensure on-time labeling, accurate proofs, and proper labeling

Qualifications

• 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.

Responsibilities

• Set 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 use at Catalent.
• Maintain accurate and complete records of kit numbers utilized by Catalent.
• Create packaging configurations in the GSA system.
• Create label print requests against approved kit list and label design specifications.
• Work closely with project management to ensure 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.
• Clean, maintain, calibrate, and adjust printer settings; operate label printers and verify barcodes.
• Troubleshoot printer issues and manage vendor escalations.
• Order and maintain label inventory with Supply Chain.
• Verify scope documents for accuracy and approvals.
• Participate in project kick-off meetings to establish label requirements.
• Manage and maintain logbooks for label design activities.
• Set up routers, create master BOMs, and generate work orders for label printing.
• Allocate label lots to pick lists and manage label stock inventory.

Skills

Communication

Problem-solving

Project management

-English proficiency

Written/verbal communication

Education

High School Diploma or GED

Tools

Label Management Software

Global Scan Assembly (GSA)

Job description

Catalent’s Kansas City facility is seeking a Label Process Specialist to manage the entire label process from project management through printing and verification. The role involves preparing, coordinating, and generating clinical study and commercial labels, maintaining kit lists, and ensuring regulatory compliance.

The position is 100% onsite in Kansas City, MO. The candidate will work with project management and suppliers to ensure on-time labeling, accurate proofs, and proper labeling