Quality Assurance; QA Compliance Specialist II

Position: Quality Assurance (QA) Compliance Specialist II
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, One Track.
• Initiate Change records to drive change management.
• Support collection of information and feedback across manufacturing sites and affiliates.

Qualifications:

• 4+ years’ experience. Bachelor’s Degree in a 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 a Regulatory Pharmaceutical Industry.

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