BD Urology and Critical Care a BD Company is seeking to fill the position of Labeling Coordinator in Covington, GA. Bard Medical has joined BD together, advancing the world of health.
The Division Labeling Coordinator works in the Research and Development Department and administers the approval of labeling artwork for labels of finished medical devices, and primary and secondary barcode label copy portion of the Device Master Record and implementation of UDI (Unique Device Identification) Requirements. This position includes this general function, as well as other duties in support of the approval of labeling in the electronic document management system (EDMS).
1) Preparation of Artwork Approval Folders - Responsible for clearly communicating and working with representatives of the Regulatory Affairs and Marketing Department to obtain the “words and phrases” and preliminary label design layout via appropriate software, for product labeling. Accurate proofreading is essential.
2) After Approval of Artwork, Initiate Preparation of Artwork/Proofs and Electronic Files - Responsible for clearly communicating and transmitting label copy information to graphic artists/printers. Knowledge of the corporate labeling and Logo standard is necessary, as well as making judgments about labeling issues based upon general knowledge of FDA Device labeling requirements.
3) Artwork Administration - Upon creation or receipt of artwork or proofs, proofread them and circulate for sign off and approval and maintain artwork/proof files, including artwork tracking and retrieval.
4) Assist in completion of projects that have:
a) Label creation
b) Label specifications/change
c) Printed package labeling revision requirements
• Proficient in the use of a personal computer with intermediate level of keyboarding skills with proficiency in Microsoft Word, Excel, and PowerPoint.
Required to sit, talk, hear, stand, bend, reach with hands, lift or move up to 25 lbs. (archive record boxes). Vision requirements include ability to see and interact with a computer.
This position works in a normal office environment. The noise level in the work environment is quiet to moderate.