Clinical Supply Packaging Operator

About the role

The Clinical Supply Packaging Operator supports secondary packaging and distribution of clinical supplies for US Medical Affairs in Fort Worth, Texas. Additional responsibilities include shipment tracking, drug accountability, processing drug returns and environmental sustainability efforts.

Responsibilities

• Labeling/Kitting, Distribution, and Accountability Activities
• Secondary packaging; apply regulatory-compliant labels to drug supplies on packaging lines (15-25°C or 2-8°C conditions), following written procedures to maintain industry regulations.
• Preparing clinical shipments of drug products to be shipped to clinical sites, including quality checks throughout the process. Shippers can weigh up to 20-25 lbs.
• Accurately receive drug from Novartis Supply Chain and verify drug supply detail, including quantity, batch number, and expiry date, ensuring compliance with stringent quality standards.
• Conduct thorough inspections, cleaning, and verification of returned shippers and their components to ensure all materials meet quality standards.
• Process site medication returns and prepares for destruction in collaboration with external vendors.
• Archives records and other key documents to provide traceability for every aspect of secondary packaging and distribution of medication.
• Demonstrates an understanding of Novartis systems, cGMP, and Annex 13 regulatory requirements such that clinical supplies documentation produced and distributed remain compliant throughout the chain of custody.
• Demonstrates good working knowledge of inventory management best practices. This may be inclusive of any of the following, logbooks and their correct entry, quarantine, retention samples, reference samples, released goods, returned and discarded goods.
• Maintain good housekeeping throughout GMP facility, always ensuring audit ready.
• Leverages AI-enabled insights and automation to optimize end-to-end clinical supply planning, execution and drug distribution through systems and processes by improving forecasting, inventory strategy, warehousing, depot-to-site distribution, risk detection, and cross-functional decision-making—while championing responsible AI adoption, governance, and continuous team upskilling.

Requirements

• Experience with labeling, packaging, and/or shipment of clinical supplies.
• High School Diploma.
• Knowledge of data entry in warehouse management systems.
• Knowledge of cGMP, 21 CFR Part 11, and Annex 13 requirements.
• Great attention to detail.
• Excellent organizational and documentation skills.
• Excellent communication & customer relation skills.

Qualifications

Novartis is unable to offer relocation support: please only apply if accessible. Company will not sponsor visas for this position.