We are currently seeking a Document Control Coordinator in
Duration: May be temporary to hire for the right person!!
Pay Rate: $20.00- $23.00
* Provides support in a GMP production/development environment
* 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