Supplier Quality Specialist

About the role

CornerStone Professional Placement is seeking a Supplier Quality Specialist for a well-established organization in Lewisville, TX. This role focuses on supplier qualification, external audits, corrective actions, supplier performance, and regulatory compliance within a GMP-regulated environment.

Responsibilities

• Conduct supplier qualifications, assessments, and audits for external manufacturers and suppliers.
• Manage supplier CAPAs, audit findings, deviations, nonconformances, and corrective actions through closure.
• Monitor supplier performance using quality metrics, scorecards, trends, and risk-based oversight.
• Maintain supplier quality documentation and support quality agreements and audit readiness.
• Collaborate cross-functionally to resolve supplier quality issues and compliance risks.
• Support internal audits and external regulatory inspections as needed.

Qualifications

• Bachelor's degree in Science, Technology, Engineering, Mathematics, or a related scientific or technical discipline.
• 5+ years of experience in Supplier Quality, Quality, Engineering, or Manufacturing within a GMP-regulated environment.
• 3+ years of audit experience, including hands-on supplier, vendor, or external manufacturing audits.
• Experience with supplier qualification, CAPA management, corrective actions, and supplier performance monitoring.
• Knowledge of GMPs, FDA regulations, quality systems, audit protocols, and inspection requirements.
• ASQ certification such as CQA, CQE, CPGP, CFSQA, or similar required.
• Experience in pharmaceutical, OTC, personal care, cosmetics, or dietary supplements preferred.
• Experience with systems such as Agile, TrackWise, Veeva, SAP, JDE, eQMS, LIMS, ERP, or PLM is a plus.

Pay

$35-$40/hour BOE

Schedule

Onsite in Lewisville, TX five days per week for the first 90 days, with potential for a hybrid schedule of 1-2 remote days per week thereafter.