Documentation Specialist(R&D)

2 weeks ago

Covington, United States MILLENNIUMSOFT Full time

Position : Documentation Specialist(R&D)

Location : Covington, GA

Duration : 6 Months Contract

Shift timings : 1st shift

Total Hours/week : 40.00

Description:

  • The Documentation Specialist works in the Research and Development Department and administers the approval of labeling artwork for labels of finished medical devices, and the primary and secondary barcode label copy portion of the Device Master Record.
  • The specialist will be involved with the implementation of UDI (Unique Device Identification) labeling. 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 Duties and Responsibilities including the following. Other duties may be assigned.

  • Labeling
  • 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, for product labeling.
  • 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.

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