QA Auditor - cGMP/Regulatory Compliance (Travel 20-30%)

Nutramax Laboratories; Lancaster (SC); Presencial; USD 75 000 - 110 000; Tempo integral

Resumo da oferta

Nutramax Laboratories seeks an Experienced QA Auditor to strengthen the Internal Compliance program and ensure regulatory adherence. This role will conduct internal and external audits, manage supplier qualifications, and oversee SCAR processes within Qualityze and related systems.

Responsibilities include coordinating audit plans, assessing risk, driving CAPA actions, and preparing for regulatory inspections.

Qualificações

• Minimum 5 years of Quality Assurance auditing experience in a cGMP environment.
• Experience with FDA-regulated industry audits is required.
• ASQ CQA certification is preferred.
• Proficiency with SAP QA functions and Qualityze QMS.
• Strong documentation, CAPA and corrective actions experience.

Responsabilidades

• Plan, schedule, and execute internal and external audits for compliance with regulations.
• Audit external vendors and manage supplier qualification including Approved Vendor List.
• Manage supplier corrective action requests (SCAR) and related documentation in QMS.
• Assess risk of findings and ensure corrective actions address root cause and preventive measures.
• Support regulatory inspections and provide audit metrics to management.

Conhecimentos

Quality Assurance

Auditing

Regulatory compliance

CAPA knowledge

Travel 20-30%

Formação académica

B.A. or B.S. in Science or Technical field

ASQ Certified Auditor (CQA) preferred

Ferramentas

SAP QA functions

Qualityze QMS

MS Office

Descrição da oferta de emprego

Nutramax Laboratories seeks an Experienced QA Auditor to strengthen the Internal Compliance program and ensure regulatory adherence. This role will conduct internal and external audits, manage supplier qualifications, and oversee SCAR processes within Qualityze and related systems.

Responsibilities include coordinating audit plans, assessing risk, driving CAPA actions, and preparing for regulatory inspections.