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DOCUMENT CONTROL CLERK

Location: Plainsboro
Posted on: May 6, 2021

Job Description:

We are currently seeking a Document Control Coordinator in Plainsboro, NJ.



Duration: May be temporary to hire for the right person!!


Pay Rate: $20.00- $23.00



JOB DESCRIPTION:


* Provides support in a GMP production/development environment (medical device)


* Responsible for and control of all validation records, design control documents and DHR files.


*Management of Quality Agreements, Quality Plans, and Management Reviews. *Processing of SOPs, Reports, validations and other controlled documentation as assigned.


*Coordinating efforts for the control of new and updated Quality System procedures for ISO 13485/QSR.


*Tracking, follow up, and implementation of ECO?s, ECN?s, validation records, design control documents and DHR?s.


* Capable of both written and verbal effective communications skills including presentations as assigned.


* Excellent computer skills (Microsoft Office programs), Solid organizational and document management skills.


*General knowledge of FDA/QSR regulations; ISO 13485 -2003, CMDR and Medical Device Directives.


*Document Control Management Databases: Documentum and/or QUMAS or any other web based Document Control Systems.


* Education: High School degree at the minimum; business degree or related acceptable relevant experience.


*Type and Number Years of Experience: 1+ years of relevant GMP/GLP experience.

Keywords: , Trenton , DOCUMENT CONTROL CLERK, Healthcare , Plainsboro, New Jersey

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