Job Description: The Clinical Supply Packaging Operator supports secondary packaging and distribution of clinical supplies for Innovative Medicines US Clinical Supply Management in Fort Worth, Texas. Additional responsibilities include shipment tracking, drug accountability and copying/filing of GMP documentation.
Responsibilities:
Responsible for labeling/kitting, distribution and accountability activities in support of the Medical Affairs portfolio.
Generates secondary packaging and distribution instructions; creates airbills and other shipping documentation.
Demonstrates an understanding of client systems, cGMP, and Annex 13 regulatory requirements such that clinical supplies documentation produced and distributed remain compliant throughout the chain of custody.
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.
Accountability 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.
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
Skills:
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.
Education
High school diploma
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 18.00/hr.
