Labeling Documentation Specialist

Location: Covington, GA • 12+ month contract • 40 hours/week (1st shift) • W2 only (US citizens or Green Card holders)

About the Role

A successful applicant for the Labeling Documentation Specialist position must possess strong documentation skills using Microsoft Word and Adobe software, excellent written and verbal communication skills, and the ability to facilitate the approval of accurate and compliant product labeling. This role works within the Research and Development Department, supporting the approval of labeling artwork for finished medical devices in an Electronic Documentation Management System (EDMS).

Responsibilities

• Manage the labeling work stream for revisions to medical device product labeling.
• Accurately communicate the labeling process and prepare timelines.
• Prepare labeling files/folders containing labels to be revised or created, including supporting documentation for review.
• Perform redlining and editing of documents using MS Word and Adobe Acrobat.
• Collaborate with cross-functional teams (Regulatory Affairs, Quality, R&D, and Marketing) to obtain labeling content and preliminary design layouts.
• Track and monitor the approval of labeling and rework.
• Route label copy for electronic review and approval.
• Communicate label copy information to graphic artists/label designers.
• Proofread to ensure accurate implementation of redlines.
• Apply knowledge of ISO standards for medical device labeling, logo standards, and FDA device labeling requirements.
• Proofread artwork/proofs, circulate for sign-off, and maintain artwork/proof files, including tracking and retrieval.
• Release documents to manufacturing for specification development using an Electronic Documentation Management System.
• Assist personnel with locating specifications, project documentation, and drawings.
• Create change requests for labels using EDMS and change control software.
• Work in a highly regulated environment.

Requirements

• High proficiency in Microsoft Word, Excel, PowerPoint, and Adobe Acrobat Pro.
• 2-year Associate Degree or higher.
• Ten or more years of job-related experience as an administrative assistant, including document revisions using Microsoft Office and Adobe Pro.
• Experience collaborating with teams in a regulated field (knowledge of medical products preferred).
• Familiarity with technical wording and documentation.
• Excellent oral and written communication skills in English; bilingual (Spanish) is a plus.
• Basic mathematical abilities (addition, subtraction, multiplication, division) and some knowledge of algebra/geometry.
• Ability to apply common sense to carry out instructions and solve practical problems.

Skills

• Extreme attention to detail and strong organizational skills.
• Ability to work independently and remotely with direction.
• Proficiency in keyboarding and personal computer use.
• Ability to sit, talk, hear, stand, bend, reach, and lift/move up to 25 lbs (archive record boxes).
• Vision requirements: ability to see and interact with a computer.

Work Environment

This position operates in a normal office environment with quiet to moderate noise levels.