Labeling Documentation Specialist (Covington, GA)

Becton Dickinson Medical Devices • Madison, WI

1d • Onsite

About The Position

We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. A successful applicant for the Labeling Documentation Specialist position must possess documentation skills using Microsoft and Adobe software and must have excellent written and verbal communication skills. Must be organized and extremely detail-oriented and able to facilitate the approval of accurate and compliant product labeling. The Labeling Documentation Specialist works in the Research and Development Department, under direct supervision facilitating and tracking the approval of labeling artwork for finished medical devices. This position includes the below responsibilities, as well as other duties in support of the approval of labeling in an Electronic Documentation Management System (EDMS).

Requirements

• 2-year Associates Degree or higher, required.
• 1-3 years of job-related experience working in the medical device field (preferably in Labeling).
• A working knowledge in the use of a personal computer and mid-high level keyboarding skills.
• Proficiency in Microsoft Word, Excel, PowerPoint, Outlook (email/meetings), Teams, and Acrobat Adobe
• Knowledge of medical products, labeling FDA/ISO standards preferred or experience in a regulated field.
• Familiarity with technical wording and documentation.
• Ability to apply common sense understanding to carry out instructions furnished in oral, written, or diagram form.
• Ability to solve practical job-related problems or recognize the need to ask supervision for assistance.
• Excellent oral and written communication skills in English are required

Nice To Haves

• Bachelor Degree or Higher preferred
• Bilingual Spanish a desirable additional skill.
• Basic mathematical abilities of addition, subtraction, multiplication, and division are required.
• Some ability to apply basic concepts of basic algebra and geometry are desirable.

Responsibilities

• Demonstrates knowledge of, and the ability to apply, labeling procedures and processes.
• Accountable for the execution of specific tasks with oversight from a supervisor and/or team lead.
• Clearly communicate and work with representatives from cross-functional teams including representatives from Regulatory Affairs, Quality, R&D and Marketing.
• Prepare Labeling electronic Files/Folders containing labels to be revised or created, including supporting documentation for review – Including redlining and editing documents using MS Word and Adobe Acrobat.
• Creation and routing of Change Requests for labels using the Electronic Documentation Management System and change control software.
• Proofread to ensure accurate implementation of redlines.
• Supports bar code scanning activities and documentation.
• Supports the labeling work stream for revisions to medical device product labeling.
• Track and monitor the approval and rework of labeling.
• Assist personnel with locating specifications, project documentation, drawings, etc.
• Work in a highly regulated environment.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree
• Number of Employees: 5,001-10,000 employees