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Document Control Specialist II

Company: Global Channel Management, Inc.
Location: New York
Posted on: June 15, 2019

Job Description:

Document Control Specialist II needs IVDR Documentation Specialist experience Document Control Specialist II requires: Broad-based knowledge and skills in Quality Assurance, Quality Systems, GMP Operations. Good working knowledge of related functions such as operations and laboratory operations. Basic knowledge of FDA Quality Systems Regulations, CMDR and ISO13485 standards. Demonstrated knowledge of business impact of compliance issues. Ability to use Microsoft Office products effectively (Outlook, Word, Excel). Highly organized. Associates Degree Document Control Specialist II duties: coordinate the receipt and handling of all records in the Product Quality (Regulatory Affairs) department which includes Grant access of personnel into the controlled Product Quality area. Logging records received into a database. Stamping records or ensuring they are stamped with the date/time. Verifying records received to the applicable log form. Creating the physical Device History files that are used to file reviewed/approved Device History records. Filing records appropriately into the correct Device History files or other filing location. Retrieval of records for FDA or other audits. Archiving records as needed. Retrieves and verifies accuracy of printed Device History records. Stages printed Device History records for retrieval by its applicable department. Prepares and verifies accuracy of Certificates of Analysis and Certificates of Manufacturing. Uploads approved CoAs and Antigrams to applicable electronic systems.

Keywords: Global Channel Management, Inc., New York , Document Control Specialist II, Other , New York, New York

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