DOCUMENT CONTROL CLERK

Location: Plainsboro
Posted on: May 5, 2024

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: , West Babylon , DOCUMENT CONTROL CLERK, Healthcare , Plainsboro, New York