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.
Key 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
Bachelors 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.
Work Environment
This position will be onsite in Lewisville, TX five days per week for the first 90 days, with the potential for a hybrid schedule of 12 remote days per week thereafter.
Why This Opportunity?
This is an excellent opportunity to make a direct impact on supplier quality, regulatory compliance, and continuous improvement while partnering with cross-functional teams in a highly regulated environment.