Clinical Supplies Operator/Labeling Specialist
Fort Worth Metro Area, Texas
1. Responsible for labeling/kitting, distribution and accountability activities in support of the Ophtha Pharma portfolio
2. Generates secondary packaging and distribution instructions; creates airbills and other shipping documentation
3. Demonstrates an understanding of Novartis s systems, cGMP, and Annex 13 regulatory requirements such that clinical supplies documentation produced and distributed remain compliant throughout the chain of custody.
4. Creates, updates, reviews, maintains and archives records and other key documents to provide track and trace evidence for every aspect of the secondary packaging and distribution of investigational product in a cGMP state.
5. Accountability for specific record types will be based on job assignments. Clinical label creation, printing and checking is a part of this job assignment; therefore, one must demonstrate knowledge of labeling requirements along with the knowledge of printing clinical labels.
6. Demonstrates good working knowledge of inventory management best practices. This may be inclusive of any of the following, log books and their correct entry, WIP, quarantine, retention samples, reference samples, released goods, returned and discarded goods
- Some experience in clinical trials or relevant clinical experience
- Excellent organizational and documentation skills
- Excellent communication & customer relation skills.
- Some experience with labeling, packaging and/or shipment of clinical supplies is a plus.
- Knowledge of cGMP, 21 CFR Part 11, and Annex 13 requirements preferred
- Excellent written and spoken English.
- Great attention to detail