Quality Systems Project Coordinator

Spectraforce Technologies
United States, Illinois, North Chicago
Feb 11, 2025
Job title: Quality Systems Project Coordinator Duration: 24 months Location: Waukegan Rd, North Chicago, IL - Onsite to start, but open to Hybrid down the line A minimal 60% on-site role (Tuesday, Wednesday, Thursday). Preference for 100% on-site at the beginning until proficiency in day-to-day tasks is demonstrated. Basic Requirements: Bachelor's degree in Pharmacy, Engineering, Chemistry, Biology, or Microbiology, or relevant course of study. Equivalent industry experience could be accepted in lieu of a degree. 5+ years of professional experience would be ideal with 2+ years of experience in specific programs or processes pertinent to the customer. Minimum supervision is expected. Proficiency in Microsoft Office tools and applications (e.g., Excel) Must Haves: Experience in Change Management principles and supporting systems and managing change activities/Experience in managing change control/change management activities. GXP Pharmaceutical experience, Biologics, Medical Devices, or other regulated industry Quality systems knowledge and related experience Data Entry Skills/Experience: GxP Pharmaceutical experience, Biologics, Medical Devices or other regulated industries. Experience in technical writing within a GxP-regulated environment (i.e., regulatory writing). Preferred: TrackWise, or equivalent, Quality Management System software/eQMS Duties include: 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. 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 with relevant stakeholders, and requesting support as needed. Pulling status reports for tracking, broad audience dissemination, and leader review. Job Description: This role reports to the Associate Director, Quality Systems Excellence. R&D Global Quality Systems (GQS) is responsible for development, deployment, maintenance, and continuous improvement of the Quality Management System for Research and Development (R&D). The RDQA Quality Systems Coordinator position executes and supports the objectives of this organization to ensure that quality management systems are effectively implemented across R&D and allow the development of high quality, safe and effective products in compliance with global regulatory requirements and applicable policies, processes, and procedures. The RDQA Quality Systems Coordinator provides operational support to departmental projects or larger-scale department/function-wide efforts.