Quality Assurance Specialist – Supplier Quality

Responsibilities

• Support the qualification, onboarding, and ongoing management of suppliers, vendors, and service providers.
• Maintain supplier quality documentation, including qualification records, quality agreements, audit reports, and supporting documentation.
• Collapse coordination of supplier assessments, audits, and periodic supplier evaluations.
• Participate in supplier audits and review documentation related to quality systems, compliance, and corrective actions.
• Collaborate with sourcing, procurement, quality, operations, and other cross-functional teams to support supplier-related activities.
• Manage supplier communication processes and support supplier change management initiatives.
• Review supplier notifications and coordinate cross-functional impact assessments.
• Monitor supplier performance metrics and track quality-related issues.
• Support investigation, documentation, and follow-up of supplier CAPAs and corrective action plans.
• Maintain accurate records within quality systems and tracking tools.
• Drive timely closure of supplier quality action items and commitments.
• Support continuous improvement initiatives focused on supplier quality, risk mitigation, compliance, and operational excellence.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Chemistry, Biology, or a related technical discipline, or equivalent experience.
• 2–5 years of experience in a regulated manufacturing, quality, supplier quality, or technical operations environment.
• Experience supporting supplier qualification, supplier assessments, supplier audits, and vendor management programs.
• Working knowledge of GMP, GxP, quality systems, and regulatory requirements.
• Experience with CAPA, change control, deviation management, and supplier performance monitoring.
• Strong organizational skills with the ability to manage multiple priorities and deadlines.
• Excellent communication and cross-functional collaboration skills.

Preferred Qualifications

• Experience participating in or leading supplier, internal, or external audits.
• Knowledge of risk management methodologies and continuous improvement principles.
• Experience supporting advanced manufacturing technologies or pharmaceutical/biotech operations.
• Familiarity with quality management systems and supplier quality software tools.