USA - QA Associate QMS Support

The Drug Supply Packaging Coordinator supports secondary packaging and distribution of clinical supplies for US Clinical Development Medical Affairs in Fort Worth, Texas. Additional responsibilities include shipment tracking, drug accountability and copying/filing of GMP documentation.Major Activities:1. Responsible for labeling/kitting, distribution and accountability activities in support of the US Pharma portfolio.2. Generates secondary packaging and distribution instructions; creates airbills and other shipping documentation.3. Demonstrates an understanding of *** 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. ccountability for specific record types will be based on job assignments. If label printing is a part of job assignments, demonstrates 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 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 skillsExcellent communication & customer relation skills.Excellent written and spoken English.