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QA Compliance Specialist

QA Compliance Specialist

Spectraforce TechnologiesWaukegan, IL, United States
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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 notifications
  • Evaluate Change Notifications to determine impacted materials and manufacturing sites using SAP, OneTrack
  • Initiate Change records to drive change management
  • Support 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, Documentation
  • English is the first language and a candidate with previous supplier change notification will be preferred.
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    Compliance Specialist • Waukegan, IL, United States