Our client, a leading pharmaceutical company, is hiring a Document Specialist consultant on a contract basis.
New Brunswick, NJ/100%Onsite
Senior Specialist, Documentation Management
This role is 100% Onsite
Work Schedule: Mon – Fri, Business Hours
PDQ Functional Area Description:
PDQ Good Manufacturing Practice (GMP) serves as the Quality Assurance Unit overseeing manufacture, testing and distribution of clinical supplies (investigational products) to assure quality and compliance with Good Manufacturing Practices (GMP) and other applicable regulations and internal procedures.
Key responsibilities include:
• Drug substance and drug product batch disposition (release/reject decision), product certification and release by the EU Qualified Person, and audit of internal GMP systems/processes and suppliers/third party contractors, as
well as assist stakeholders with regulatory advice and preparation for and management of regulatory agency inspections.
Principal Objective of the Position:
• 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 Records Management Systems
• Generate metrics and support communication (i.e. upcoming periodic reviews, schedule for off-site storage and/or destruction)
Key Responsibilities and Major Duties:
• Manages day-to-day operation and compliance of the Summit 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/Celdox) 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 Electronic Document Management System (EDMS) 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