Documentation Specialist(R&D)

Essential Duties and Responsibilities

• Labeling
• Preparation of Artwork Approval Folders
• Creation of redlines for labels following good documentation practices.
• Manage the work flow for artwork approvals including redlining, label copy approvals, requests for desk top publishing, proofing and gathering approvals.
• Accurate proofreading is essential.
• Gathering and organizing documentation needed to support the approval of product labeling.
• After Approval of Artwork, Initiate Preparation of Artwork 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.
• 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.
• Projects Containing Labeling Changes
• Assist in completion of labeling efforts:
• Label creation
• Label specifications/change
• Printed package labeling revision requirements
• Assist personnel who may require help locating specifications, project documentation, and drawings.
• Creation of Change Requests for labels using the electronic documentation and change control software.
• Updating Excel spreadsheets for tracking work.

Qualifications

• 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 in Microsoft Word, Excel, PowerPoint, and Access.
• Education and/ or Experience:
• High school education or equivalent. At least 2 years of college preferred.
• Two or more years of job-related administrative experience. Organized, detailed and achievement oriented. Working with camera-ready artwork, suppliers of graphic arts media and printers preferred. Knowledge of medical products and labeling requirements preferred.
• Experience in word processing and Excel required.
• Familiarity with technical wording and documentation.
• Language Skills
• Excellent oral and written communication skills in English are required, with abilities in Spanish a desirable additional skill.
• Mathematical Skills
• Basic mathematical abilities of addition, subtraction, multiplication and division are required. Some ability to apply basic concepts of basic algebra and geometry are desirable.
• Reasoning Ability
• 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
• Physical Demands
• 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.
• Work Environment
• This position works in a normal office environment. The noise level in the work environment is quiet to moderate.