Position Title : QA Compliance Specialist / Quality Systems Specialist
Work Location : Waukegan, IL 60085 (Lakeside Drive) 100% Onsite
Assignment Duration : 6 months (Possible Extension)
Work Schedule : First Shift, Monday - Friday, overtime will be based on business need
Work Arrangement :
- Office setting. Much of the work can be performed independently, but there will be a need to meet and interact with the team for training and general communication.
Position Summary :
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.Top 3-5 skills needed
4+ years' experience. Bachelor's degree in science or engineering field. Master's preferred but not required.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 the Regulatory Pharmaceutical Industry.Experience in managing and finding resolutions from complex situations or that are not well defined, in a timely fashion.Responsibilities
Monitor global Supplier Change Notification inbox for change notificationsEvaluate Change Notifications to determine impacted materials and manufacturing sites using SAP, OneTrackInitiate Change records to drive change managementSupport collection of information and feedback across manufacturing sites and affiliates.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.Experience in Quality, Change Control, CAPA, Operations, DocumentationEnglish is the first language and a candidate with previous supplier change notification will be preferred.