Description
QUALIFICATIONS Document-Labeling Specialist, Nov.2015 - Feb.2016 Well-versed communicator, high organizational and analytical (Contract Position Only) abilities. Work well independently and as a member of a * Creation, Revision of CGL, pre-printed labels and IFU via team. Adept in SUSARs, IRB submissions, Sponsor redlining documents and SOP standards. monitoring, and CTMS files. Efficient at handling multiple regulatory documents and adhering to GCP, GLP, FDA * Represent labeling on core team and project team on guidelines/ regulations. labeling and document requirements per ISO, cGMP, and FDA guidelines. * Updating PLM Edwards Ignite database on affected
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