Quality Assurance Auditor at Masis Professional Group in Charlotte, North Carolina

Quality Assurance Auditor

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

This role 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-Haves:

• 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).

What You'll Do:

• 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:

• ASQ Certified Quality Auditor (CQA) preferred.
• SAP and Quality Management System experience.

? Outstanding Benefits & Relocation Package!?

• 45 Days of Fully Furnished Temporary Housing
• $5,000 Relocation Stipend
• Paid Area Exploration Visits
• Weekly Pay
• Christmas Eve-New Year's Shutdown
• Up to $5,000 Annual Tuition Reimbursement
• Gym/Fitness Reimbursement
• Company-Paid Life Insurance
• Company-Paid Short-Term Disability
• Employee Assistance Program (EAP)
• Annual HSA Contribution
• Daycare & Private School Tuition Assistance

A company that truly invests in its employees and their families!