Company Description
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 Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.
Job Description
The associate will provide 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.
Qualifications
Essential Duties and Responsibilities
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 worklows
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)
- 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
Education and Experience:
- Bachelor’s 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.
Additional Information
All candidates must be legally eligible to work in the United States.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***