Document Coordinator-Rensselaer NY (REF8547Z)
Company: Propharma Group
Posted on: January 16, 2022
ProPharma Group is an industry leading, single source provider for
regulatory compliance, pharmacovigilance, and medical information
services across the full development lifecycle for pharmaceutical,
biotechnology, and medical device companies. Operating around the
world with offices in Australia, Canada, Germany, Japan, the
Netherlands, Sweden, United Kingdom, and the United States,
ProPharma Groups fully integrated service offerings will provide
clients with a comprehensive suite of global support services that
are required to be competitive in todays dynamic markets. We build
successful long-term relationships with clients by providing
leading industry knowledge, experience, and proven processes.
The associate will provide support to the process for creating,
reviewing, approving, distributing, controlling and maintaining
documentation to ensure effective and efficient application of
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.
Essential Duties and Responsibilities
- 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 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
- Maintains document integrity as per procedure
- Performs basic troubleshooting of worklows
- 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)
- 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
- Collects and compiles data to support metric analysis required
for understanding of system or process performance, or
- 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
- 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.
- Participates in inspection and audits by supporting the
supplies requested information to Doc Control inspection team
Education And Experience
- Bachelors degree with 0 years relevant experience or
- Equivalent combination of education and experience
Knowledge, Skills, And Abilities
- Knowledge of document databases and other electronic document
management tools (e.g.
eDocCompliance, FileMaker Pro).
- Attention to detail and organizational skills.
- Ability to work independently with moderate supervision.
- Ability to work in a team environment.
- Ability to work well under time restraints.
- Experience with Microsoft Office Word, PowerPoint, Excel,
Access, and Outlook.
All candidates must be legally eligible to work in the United
***ProPharma Group does not accept unsolicited resumes from
recruiters/third parties. Please, no phone calls or emails to
anyone regarding this posting.***by Jobble
Keywords: Propharma Group, Albany , Document Coordinator-Rensselaer NY (REF8547Z), Other , Rensselaer, New York
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