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ProfileDocument Control Specialist Duties: Maintain compliance in the areas of document control and supplier control for company as well as clients in support of company’s strategic plan. Act as Document Control for numerous clients in order to process all documents through both internal and external systems in a timely manner. All client COs/DCOs/DCRs are closed in a timely manner. Own ensuring the follow up actions make it to completion. Maintain a computer database of all filed documentation that ensures fast retrieval of documents. Maintain the flow of both electronic and hard-copied controlled documents, department files and resource materials. Timely distribution of latest revision level documentation to all appropriate users and ensure that obsolete documentation is removed from distribution. Coordinate document control issues between external subcontractors and service providers. Maintain Master Document Control Log and Files. Review change orders and for completeness and accuracy. Maintain all client training as well as Group consultants’ internal training up to date and accurate. All logs and files are to be maintained. Maintain all client as well as Group external standards up to date and accurate.. All logs and files are to be maintained. Maintain external documents (standards) to ensure the company complies with all applicable standards and regulations. Edit and assist in drafting new Quality System Procedures. Document control specialists must be able to recognize problems, recommend solutions and put the solutions into action. Be involved in the training of other team members. Complete projects (including system enhancements) in a manner consistent with corporate objectives. Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations.
Qualification and Experience
REQUIREMENTS: High school diploma, with some college or equivalent appropriate industry experience. Editing or technical writing experience is a plus. An English major. A paralegal background. Strong background and in editing or proofreading. Proficient in MS Word. Excellent word retention and recall. Work experience in medical device industry a strong plus. Background in editing or documentation management. Must be able to follow multiple projects through to completion. Enjoy editing, proofreading and formatting. Proficient and thorough reader. Ability to perform word processing and create basic spreadsheets, as well as work in Adobe and numerous on-line media. Ability and willingness to learn/ use new software programs. A high attention to detail and orderly focus.
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