Job Description

The Documentation Specialist is responsible for the review, issuance, and control of procedures, forms, test methods, and reconciliation throughout the organization. The Documentation Specialist will assist in maintaining employee training files and training curriculums to ensure employees remain current in their assigned training.

Essential Duties & Responsibilities

• Issue and control, but not limited to, Master Batch Records, Controlled Forms, Logbooks, Test Methods, Protocols, and Reports.
• Issue and route Document Change Requests (DCRs) in the Electronic Document System.
• Assist in scanning all batch records, validation documentation, calibration information, and supporting documentation, and post on the company portal as needed.
• Perform audits of issued Controlled Forms, Master Batch Records, and Logbooks to finalize reconciliation and ensure timely return of documents for final archival.
• Receive documentation and ensure documents are properly archived and easily retrievable.
• Ensure documents are properly formatted.
• Responsible for template management to ensure harmonization among documents within the organization.
• Track and trend lead times for Document Change Requests.
• Provide weekly status updates to upper management for all pending document reviews in the Electronic Document System.
• Provide Help Desk support to users of the documentation system, including creation and monitoring of incident tickets requiring support from the Electronic Document System Administrator.
• Assist change originators in the coordination of document releases.
• Identify and implement efficiency improvements to the overall document control process.
• Assist the training team by tracking and trending training files to complete training modules.
• Upload PDF versions of procedures to the corporate portal.
• Manage a broad spectrum of projects to support the needs of Quality Management.
• Perform other duties and responsibilities as delegated by Quality Management.

Experience/Qualifications

• A bachelor’s degree from a four-year university/college in life science, computer science, or other related field; or 5+ years of experience in a training and/or document control capacity, preferably in a cGMP-regulated industry.

• Previous experience working in a training capacity is desired. Experience commensurate with position level.
• Previous experience with electronic document management systems is desired. Experience commensurate with position level.
• Previous work in a cGMP industry is desired.

• MasterControl™ Electronic Document Management System Operation certification is preferred.

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