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DI CSV Document Controller

4 months ago

Western Springs, United States ProPharma Group Full time

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world's largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs.

Document controllers follow established document process flows to ensure the integrity and control of documents per site and company standards. This includes understanding the cross linking of documents and the affect of changes within the document structure.

Essential Functions

  • 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
  • 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
  • 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.
  • Generates reports and interprets data on a pre-defined basis needed to support process understanding, customer information requests, and visibility of organization activities
  • Runs standing metrics reports for Quality Operations Systems Metrics meeting, Right to Operate meeting, and other performance review meetings
  • 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
  • Participates in inspection and audits by supporting the associated logistics
  • Supplies requested information to Doc Control inspection team
  • Supports team members by acting as site escort as needed.
  • Other duties as assigned.
Necessary Skills and Abilities
  • Experience in documentation systems.
  • Able to work effectively with local and virtual team members and other professionals, such as QA specialists, software developers, and system users
  • Effective written and oral communication skills; ability to write, type, express or exchange ideas of a technical nature by means of the spoken word; convey information/instructions accurately; receive detailed information through oral or written forms and to translate those instructions into physical execution of tasks.
Educational Requirements
  • Bachelors degree required
Experience Requirements
  • minimum 4 years experience.


We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***