GMP Document Coordinator
The Document Coordinator is responsible for processing all Standard Operating Procedures (SOPs) and for the daily management of the SOP program. This position is also responsible for the tracking and management of Quality Controlled Documents. Routine contact with all organization levels and departments is required through verbal and written communication. This position will also routinely provide administrative support for External audits (FDA, ISO, Global, etc) and to the Quality Systems group, when needed.
Process SOPs in eDOCs and at a later time, MANGO, to include reviewing, routing, promotion of effective documents, copying and distributing copies.
Maintain the Annual SOP Review Process, which includes sending monthly notifications of SOPs to be reviewed, issuing periodic SOP status reminders, completing monthly reports. Manages process for review of Corporate Policies update to ensure local changes are made as necessary to maintain compliance with the Corporate Policies.
Provide administrative support for internal and external audits.
SCOPE OF POSITION:
The GMP Document Specialist is responsible for processing all Standard Operating Procedures (SOPs) and for the daily management of the SOP program.
This position is also responsible for the tracking and management of Quality Controlled Documents Routine contact with all organization levels and departments is required through verbal and written communication.
This position will also routinely provide administrative support for internal and external audits (FDA, ISO, Global, etc) when needed.
Position will report to Supervisor.
Other task may be assigned as necessary to support the site.
Working hours: 8:00 AM - 8:00 PM
We are looking for an expert at ISO 14385 and GMP's for Class 1 medical devices.
Bachelor's degree preferred, Biology or Chemistry.
2-5 years of relevant experience and experience in a GMP regulated environment.
Demonstrated proficiency with MS Word, MS Excel, and Adobe a must.
Well organized with the ability to multi-task and shift priorities as needed to meet customer demands.
Experience with SAP preferred.
Health benefits after 45 days and 401k options/sick leave after 90 days worked.
Hours: Monday through Friday, 8am to 4:30pm
Interested? Please email resume to email@example.com or call my desk line at 951-514-4501
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