Summary: Provides support to the process for creating, reviewing, approving, distributing, 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 supervision.
Essential Duties and Responsibilities can include, but are not limited to, the following:
DOCUMENT STRUCTURE
- Understands the concept of document hierarchies and applies when executing document review.
- Performs document review against standard formats and requirements
- Understands the approval process and provides guidance to customers
- 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 workflow.
- 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 documents
- Processes document requests including intake, coordination, editing, review, and release
- Ensures collaborative review is completed prior to workflow activation
- Maintains document integrity as per procedure
- Performs basic troubleshooting of workflows
RECORDS ISSUANCE
- 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 documentation
PROCESS PERFORMANCE
- Collects and compiles data to support metric analysis required for understanding of system or process performance, or investigation activities
- Generates reports and interprets data on a pre-defined basis needed to support process understanding, customer information requests, and visibility of organization activities
- Creates basis visual management information from data for different department activities
- Runs standing metrics reports for Quality Operations Systems Metrics meeting, Right to Operate meeting, and other performance review meetings
TECHNICAL SYSTEMS
- Maintains a basic understanding of the Electronic Document Management System EDMS for processing workflows, running reports, and performing basic information searches.
- Accesses and reviews QlikSense tools, file tracking P Databases, The Document Activation Management tool, SharePoint sites, and Servers to support execution of tasks
- Maintain departmental databases.
INSPECTION SUPPORT
- Participates in inspection and audits by supporting the associated logistics
- Supplies requested information to Doc Control inspection team
COMPLIANCE SUPPORT
- Participates in investigations
GENERAL
- Identify areas for continuous improvement for processes based on experience and customer feedback.
- Participate in departmental project teams.
Years of Experience: 1
***Compensation within this range will be commensurate with level of experience***