81 Columbia Turnpike Rensselaer, NY 12144 US
Summary: Provides support to the process for creating, reviewing,
controlling and maintaining documentation to ensure effective and
efficient application of GMP.
Documentation within this process includes, but is not limited to,
manufacturing and packaging,
laboratory, and general operations. Understands the basic
principles and concepts of the
documentation lifecycle and associated electronic systems.
Performs departmental tasks under
Essential Duties and Responsibilities can include, but are not
limited to, the following:
• Understands the concept of document hierarchies and applies
when executing document review.
• Performs document review against standard formats and
• Understands the approval process and provides guidance to
• Ensures appropriate cross-referencing, links, and other required
meta-data for documents
DOCUMENT & WORKFLOW MANAGEMENT
• Perform intake review of documents for completeness and
accuracy while maintaining document
• Coordinate review and revision of controlled documents.
• Owns single to a few pre-fixes or process across multiple areas
within a site
• Executes activities associated with creation, retiring and
unretiring, and periodic review of
• Processes document requests including intake, coordination,
editing, review, and release
• Ensures collaborative review is completed prior to workflow
• Maintains document integrity as per procedure • Performs basic troubleshooting of workflows
• Executes the different steps associated with the lifecycle of a
record (including but not limited to,
Master Batch Records, Batch Sheets, Protocol Performance
Copies, Labels, Logbooks, Keys):
issuance, tracking, and reconciliation.
• Performs verification of records ensuring all required information
is present, accurate, and
compliant against procedures prior to issuing to receiving area
• Maintains an accurate and comprehensive inventory of issued