QA Change Control Specialist

Job Title: Quality Systems Specialist

Location: North Chicago, Illinois 60085

Duration: 12 Months

Description:

• 100% Onsite - hybrid can be negotiated in the future based on performance
• Normal first shift working hours: 8 am to 4:30 pm. There is opportunity for some flexibility.
• NOTE: While training, the candidate may be asked to begin the day no later than 7:00 am, as training will be provided by someone in Ireland’s time zone. This will improve availability of trainer/trainee to meet. Also- training will be onsite.

Purpose:

• The candidate is responsible for providing quality assurance support for some or all parts of the Supplier Controls Quality System. Specific areas of support include Supplier Change Notification assessment, initiation of change control/change plan activities, and request/collection of feedback from manufacturing sites and affiliates. The person will ensure compliance to the quality system as it pertains to Supplier Change Notifications.

Responsibilities

• Monitor global Supplier Change Notification inbox for change notifications
• Evaluate Change Notifications to determine impacted materials and manufacturing sites using SAP, GTW, SolTRAQs, OneTrack
• Initiate Change records to drive change management
• Support collection of information and feedback across manufacturing sites and affiliates.

Required Skills:

• 4 years’ experience. Bachelor’s Degree in a Science or Engineering field. Master’s preferred but not required.
• Familiarity with: Corrective and Preventive Actions (CAPAs), Audit processes, Document control and quality documentation management.
• Strong background in change control and change management processes.
• Experience in quality systems e.g., change controls, supplier management, deviations, documentation, CAPA, audits, experience with supplier change notifications, searching vendors in SAP, Soltraqs/Trackwise experience.
• Experience in a Regulatory Pharmaceutical Industry.
• Experience in managing and finding resolutions from complex situations or that are not well-defined, in a timely fashion.
• Skills: Excellent written and oral communication skills, detail oriented, adaptable, flexible, organized, time management skills, problem-solving skills, works well independently and cross- functionally in a fast-paced industry environment.
• English is the first language
• Experience in Quality, Change Control, CAPA, Operations, Documentation