Quality Assurance (QA) Compliance Specialist II

The Fountain Group; North Chicago (IL); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading pharmaceutical company in North Chicago is seeking a Quality Assurance Specialist to monitor Supplier Change Notifications and ensure compliance with quality systems. The ideal candidate should have over 4 years of experience in quality assurance and a Bachelor's Degree in a Science or Engineering field. Familiarity with SAP and Regulatory Pharma is essential. This role provides an opportunity to work within a dynamic team dedicated to quality management.

Qualifications

• 4+ years’ experience in a relevant field.
• Experience in quality systems and supplier management.
• Knowledge of documentation, CAPA, and audits.

Responsibilities

• Monitor global Supplier Change Notification inbox.
• Evaluate Change Notifications for impacted materials.
• Initiate change records for change management.
• Support collection of feedback across sites.

Skills

Quality assurance support

Supplier Change Notification assessment

Evaluation of Change Notifications

Experience with SAP

Regulatory Pharmaceutical Industry knowledge

Education

Bachelor's Degree in Science or Engineering

Master's Degree (preferred)

Tools

SAP

Soltraqs/Trackwise

Job description

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.

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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