Job description

Document Specialist

Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Document Specialist for our client in New Brunswick, NJ.

Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!

Position Overview:

• 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)

Responsibilities:

• 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 Client core behaviors

Qualifications:

• 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 Type: Contract

Salary: $28.00 - $30.00 per hour

Schedule:

• 10 hour shift
• 8 hour shift

Work Location: On the road

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