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Scientific. Clinical. Software Engineering

Document Specialist

Edison-New Brunswick Metro Area, NJ

Job Type: Scientific Job Number: JN -052020-26797 Region: Edison-New Brunswick Metro Area

Job Description

Responsibilities will include, but are not limited to the following:

Document control & review process of all documents in both the Veeva system platform as well as paper documents.

Will work directly with various departments to ensure documents are accurate

Organize and write supporting documents as needed

Support Periodic Review of Controlled Documents process as well as provide reports and metrics

Creation, modification, issuance, reconciliation of logbooks as well as and updates to templates

Issuance and reconciliation of Laboratory Forms

Revise documents as new issues arise and maintain revision control

80% desk review/computer work

Document Center management, reconciliation and cataloging of physical records

Document Center escort for requestors without card key access in order to review physical records

Skills/Knowledge Required:

Excellent written and communication skills

QA background and familiar with basic GMPs and Good Documentation Practices

Applicant would spend most of their time in the computer based systems related to Document Control

Develop and provide system reports and metrics on a weekly basis.

Management of physical GMP documents

Knowledge of Veeva, ComplianceWire and Deviation/CAPA systems would be a plus.

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