Document Coordinator

DOCUMENT COORDINATOR NEW BRUNSWICK, NJ This role is an Onsite role! Pay ranges between 24.50 - $28.57 an hour. 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: ALPHA'S REQUIREMENT #23-00568 MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE