Senior QA Auditor - FDA-Regulated Supplier Audits Travel

Masis Professional Group; South Carolina; On-site; USD 85,000 - 95,000; Full time

Job summary

Masis Professional Group is seeking a Quality Assurance Auditor to join a leading health and wellness manufacturer near Charlotte, NC. The role reports to the Supplier Quality and Compliance Manager and focuses on building a robust internal compliance program, audits, and CAPA execution.

The position requires at least 5 years of QA auditing experience in a cGMP environment and 5 years of external vendor/supplier audits within an FDA regulated industry.

Qualifications

• Must have a minimum of 5 years of Quality Assurance auditing experience in cGMP environment with a minimum of 5 years of external vendor/ supplier compliance auditing experience within an FDA regulated industry.
• Knowledge of the Regulations 21CFR Part(s) 210, 211, 507 as well as the Dietary Supplement Regulations 21 CFR 111 is required.
• ASQ Certified Auditor (CQA) Certification is preferred.
• Must be proficient in Computer Software applications including MS office suite.
• Must be able to travel 20 – 30% for domestic audits, (international travel may be needed per quality management).
• Plan, schedule, and conduct internal and external audits to ensure regulatory and quality compliance.
• Audit suppliers and contract manufacturers (CMOs) and maintain vendor qualification programs.
• Manage supplier corrective actions (SCARs) and verify effective CAPA implementation.
• Assess audit findings, determine risk levels, and drive corrective and preventive actions.
• Maintain audit, supplier, and compliance documentation within the Quality Management System (QMS).
• Monitor and report audit and compliance metrics to management.
• Train and support cross-functional teams on quality and compliance requirements.
• Identify compliance risks and support process improvements to mitigate risk.
• Support regulatory inspection readiness and ongoing compliance initiatives.
• Utilize SAP and electronic quality systems to support Quality Assurance activities.

Responsibilities

• Plan, schedule, and conduct internal and external audits to ensure regulatory and quality compliance.
• Audit suppliers and contract manufacturers (CMOs) and maintain vendor qualification programs.
• Manage supplier corrective actions (SCARs) and verify effective CAPA implementation.
• Assess audit findings, determine risk levels, and drive corrective and preventive actions.
• Maintain audit, supplier, and compliance documentation within the Quality Management System (QMS).
• Monitor and report audit and compliance metrics to management.
• Train and support cross-functional teams on quality and compliance requirements.
• Identify compliance risks and support process improvements to mitigate risk.
• Support regulatory inspection readiness and ongoing compliance initiatives.
• Utilize SAP and electronic quality systems to support Quality Assurance activities.

Skills

QA auditing

cGMP

FDA industry

Travel 20-30%

ASQ CQA

Tools

MS Office

SAP

Job description

Masis Professional Group is seeking a Quality Assurance Auditor to join a leading health and wellness manufacturer near Charlotte, NC. The role reports to the Supplier Quality and Compliance Manager and focuses on building a robust internal compliance program, audits, and CAPA execution.

The position requires at least 5 years of QA auditing experience in a cGMP environment and 5 years of external vendor/supplier audits within an FDA regulated industry.