DOCUMENT COORDINATOR SUMMIT, NJ This role is an Onsite role!
Pay ranges between $ 24.50 - $28.57.
Required Skills:
Bachelor's degree preferred.
Minimum 4 years of quality experience in the pharmaceutical industry.
Minimum 2 years of records management & document coordination experience using an electronic documentation system, preferably Veeva Quality Docs.
Prior experience training end users on how to use quality systems and comply with procedures.
Prior experience supporting closure of investigations and corrective actions.
Ability to support day-to-day operation of NBR records center with limited supervision.
Project Description:
Ensure compliance within the organization as it pertains to documentation and records management.
Provide support as a Content Manager of various PD Electronic Document Management Systems (e.G., DocMan) and Client's Records Management Systems.
Generate metrics and support communication (i.E., upcoming periodic reviews, schedule for off-site storage and/or destruction).
Manages day-to-day operation and compliance of the New Brunswick Records Center, including issuance, archival, charge-outs, and reconciliation of GxP physical records including but not limited to equipment logbooks, laboratory notebooks, manufacturing batch records, and equipment qualification records.
Coordinates offsite record storage and recall activities with Iron Mountain.
Serves as Records Management System (RMS) Subject-Matter-Expert (SME) to enable successful execution of workflows within the system.
Identifies opportunities for continuous improvement including need for system enhancements through partnership with Global Quality Systems and Information Technology.
Supports implementation of global quality system initiatives, including but not limited to electronic documentation systems and processes.
Utilize the Records Management System to manage hardcopy GMP documents submitted for retention and archival.
Provide support for procedural documentation requests, records management, issuance of logbooks/notebooks issuance, tracking and reconciliation for the NBR site.
Completes routine tasks with little or no supervision.
Requires moderate direction to complete more complex tasks.
Adherence to the Client's core behaviors.
This 9+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Maureen: maureen@alphaconsulting.Com
ALPHA'S REQUIREMENT #23-00970
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
