• 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.