Quality Assurance Auditor | cGMP | FDA

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

Quality Assurance Auditor | 30-45 minutes of Charlotte, NC

US Citizens or Green Card Holders only | No C2C

Salary range $85k - $95k plus discretionary bonus up to 12%

Join an industry-leading health and wellness manufacturer dedicated to improving lives through science, innovation, and uncompromising quality. With a strong reputation for excellence, the company develops trusted products backed by research and produced to the highest standards of quality and compliance.

Employees enjoy a collaborative, values-driven culture that emphasizes integrity, continuous improvement, professional growth, and making a meaningful impact every day. If you're looking to join a mission-focused organization where quality matters and people are valued, you'll feel right at home here!

The Quality Assurance Auditor reports to the Supplier Quality and Compliance Manager. This role is responsible for developing and maintaining a strong Internal Compliance program ensuring compliance to applicable regulations. The QAA is required to perform internal and external audits, prioritize audit schedules and corrective actions to the findings identified.

• 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.

Preferred:

SAP and Quality Management System experience