BD (Becton, Dickinson and Company) Product Labeling Specialist in Covington, Georgia
Job ID: 2018-12624
Career Level: experienced
Location: Covington,Georgia,United States
Bard has joined BD, together advancing the world of health. BD Urology & Critical Care, formerly Bard Medical, is looking to fill the position of Bilingual Customer Care Specialist located in Covington, GA.
Summary of Position with General Responsibilities:
The Product Labeling Specialist works in the Research and Development Department and administers the creation and approval of labeling artwork and generation of specifications for label/insert sheet components of finished product, and maintains the IFU’s, primary and secondary barcode label copy portion of the Device Master Record. 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).
Essential job Functions:
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
Accurate creation or revision of new or revised product labeling based on mark-ups, corporate graphic standards, division procedures and established formats using current graphics software.
Knowledge of the corporate labeling and logo standard is necessary, as well as making judgments about labeling issues based upon general knowledge of FDA and International Device labeling Regulations.
Prepare labeling packages for approvals. Responsible for clearly communicating and working with representatives of the Marketing and Regulatory Depts. to obtain the “words and phrases” and preliminary label design layout for product labeling.
Review/proofread labeling for accuracy and compliance to procedures. Ensure all document and system elements are identified, accurate and assembled for review and approval. Accurate proofreading is essential.
Coordinate translations as required.
Perform prepress activities necessary to prepare labeling artwork files for final approval in the Electronic Data Management System (EDMS).
Responsible for clearly communicating and transmitting label copy information to printers in electronic format.
Artwork Administration/Specification Creation - Upon creation or receipt of artwork or proofs, proofread them and circulate for approval, work with Package Engineers to prepare label/insert specifications and maintain artwork files, including artwork tracking and retrieval. Keep records of artwork expenditures for budget purposes and ensure invoices and actual artwork created are in agreement.
Work under strict deadlines and changing priorities with minimal supervision.
Manage multiple labeling changes and projects by managing long-term deadlines and anticipating project steps to ensure projects are consistently completed on time.
Work independently on labeling for New Product Development and complex Sustaining Engineering Projects.
Serve as lead in the creation of product labeling. Serve as internal technical support for labeling, for example, designing and documenting standard label templates based on pre-defined criteria.
Participate in Project Team meetings to communicate labeling development timelines.
Perform training for new labeling associates.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
- Proficient in the use of a personal computer with intermediate level of keyboarding skills with proficiency inMicrosoft Word, Excel, PowerPoint, and Adobe InDesign, Acrobat, Illustrator, and Photoshop graphic design software.
Strong team player with good problem solving and good verbal and written communication skills.
Time management and organizational skills and ability to manage multiple projects simultaneously.
Working knowledge and ability to read and understand product specifications, product layout drawings, and packaging specifications.
Education and/or Experience:
Five to ten years of job-related experience working with graphic software to create print-ready artwork.
Bachelors (or 4-7 years experience with an Associate CollegeDegree)
Knowledge of medical products.
Familiarity with technical wording and documentation.
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.
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status