Document Coordinator - New York, United States - Planet Pharma

Description

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

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