Quality Systems Coordinator

Our global pharmaceutical client is looking for R&D Global Quality Systems Coordinator. The Quality Systems Coordinator would be responsible for development, deployment, maintenance and continuous improvement of the QMS for the organization's R&D team. You would execute and support the objections of the org to ensure that quality management systems are effectively implemented across R&D and allow development of high quality, safe and effective products I compliance with global regulatory requirements and applicable policies, processes and procedures. You would provide the operational support to the R&D dept. projects.

Responsibilities:

• Support the Quality Change Management process within the RDQA and R&D organizations.
• This includes:
  
  
  
  • Initiating change records
  • Coordinating, executing and following-up on change management action plans/activities.
  • Monitoring the progress of change plans, communicating to relevant stakeholders and requesting support as needed.
  • Pulling status reports for tracking, broad audience dissemination and leader review.
  
  
  
  

* Tracking information and generating reports for communication to stakeholders, as well as direct stakeholder communication.

* Troubleshooting process/system issues for resolution and follow-through.

* Project/task schedule coordination (e.g., due dates, deadlines) and management.

This is a long-term temporary assignment(1+ year) with potential for extension, potential conversion in future. This position is hybrid, would be onsite 3 days per week within M-F and would be in the North Chicago office. There may be some travel to other locations within the area depending on meeting locations.

Requirements:

• Bachelor's Degree in Pharmacy, Engineering, Chemistry, Biology or Microbiology or relevant course study or equivalent experience
• 5+ years of experience within quality systems
• Experience with technical writing within a GxP regulated environment
• Experience in change management principles and supporting systems
• Experience working with QMS, TrackWise preferred

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