Responsible include include shipment tracking, drug accountability and copying/filing of GMP documentation
Responsible for labeling/kitting, distribution and accountability activities
Generates secondary packaging and distribution instructions; creates airbills and other shipping documentation.
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.
Knowledge of labeling requirements along with the knowledge of printing clinical labels.
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 with labeling, packaging and/or shipment of clinical supplies (preferred)
- Knowledge of cGMP, 21 CFR Part 11, and Annex 13 requirements (preferred)
- Great attention to detail.
- Excellent organizational and documentation skills
- Excellent communication & customer relation skills.
- Excellent written and spoken English.
High school diploma
Source: Job Diva – Job Listing