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.

Major Activities:
1. Responsible for labeling/kitting, distribution, and accountability activities in support of the US Medical Affairs portfolio.
2. 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.
3. 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.
4. 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.
5. Conduct thorough inspections, cleaning, and verification of returned shippers and their components to ensure all materials meet quality standards.
6. Process site medication returns and prepares for destruction in collaboration with external vendors.
7. Archives records and other key documents to provide traceability for every aspect of secondary packaging and distribution of medication.
8. 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.
9. 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.
10. Maintain good housekeeping throughout GMP facility, always ensuring audit ready.

The pay range for this position at commencement of employment is expected to be for Manager: $39,100 - $72,700 a year however, while salary ranges are effective from 1/1/25 through 12/31/25, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.