Job description

Senior Specialist, Documentation Management
This role is 100% Onsite
New Brunswick, NJ
Work Schedule: Mon - Fri, Business Hours

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 BMS 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 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 BMS core behaviors

Education and Experience:

• Minimum 4 years of quality experience in the pharmaceutical industry.
• Minimum 2 years of records mgmt. & document coordination experience using an electronic documentation

system, preferably Veeva Quality Docs.

• Bachelor's degree preferred

Job Types: Full-time, Contract

Pay: $25.00 - $27.00 per hour

Schedule:

• 8 hour shift

Experience:

• Documentation: 3 years (Required)

Work Location: In person

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