Clinical Packaging Technician - Clinical Trial Supply

Join a major pharmaceutical site in Zebulon, NC as a Clinical Packaging Technician supporting clinical trial supply operations. This is a detail-oriented, systems-based role combining floor operations and GMP documentation work in a regulated environment.

Key Responsibilities

• Print and inspect clinical labels for use in clinical trials, including bay set-up and line clearance
• Prepare data entry for primary or secondary packaging documentation in accordance with cGMPs and SOPs
• Use systems critical to the delivery of labels and packaging documentation (ClinPro, PTMS, COMET, or future applicable systems)
• Complete and verify reconciliations of labels
• Manage label and printer ribbon stock; receive and re-order as appropriate
• Ensure routine tasks (e.g. print head checks) are performed in accordance with their required schedule
• Raise any non-standard activities during label or documentation preparation to team coordinator or supervisor
• Verify equipment set-up including quality critical settings
• Participate in Quality Investigations as a technical expert when appropriate
• Participate in local and regulatory audits (compliance and safety)
• Support continuous improvement opportunities in quality, productivity and safety
• Assist in primary and secondary packaging floor operations as needed

Specific Activities Include:

• Label preparation: printing (open or blinded), checking 2D barcodes, receipt and dispensing of booklet labels, line clearance, inspect printed labels
• Documentation preparation: creation and approval of Secondary Packaging Records (SPR), ClinPro data entry (open label, double blind, expiry jobs), creation of Expiry job packages, download and importing of random codes, creation of code break container types

Requirements

• Demonstrated experience in the clinical supplies area — knowledge of GMP label creation and packaging operations to support clinical trials
• Ability to work independently with minimal supervision
• Strong attention to detail and data accuracy
• Good PC skills (email, Windows, word processing, database, spreadsheet applications)
• Ability to write documents and follow written instructions
• Good communication and interpersonal skills
• Ability to double-check the work of others for accuracy

Preferred

• Bachelor's degree
• Experience with clinical labeling systems (ClinPro, PTMS, COMET, Prisym 360 or equivalent)
• Experience with GMP documentation in a clinical supply chain environment
• Familiarity with blinded / double-blind packaging processes