Careers at Masis Staffing Solutions

QUALITY ASSURANCE AUDITOR

Charlotte, NC
Salary $75 – $95k plus up to 12% discretionary bonus
U.S. Citizens or Green Card Holders Only | No C2C
Schedule: Monday–Friday, 8:30 AM – 5:00 PM

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.  

Required 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).

Key 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.

Preferred Qualifications:

• ASQ Certified Quality Auditor (CQA) certification
• Experience with SAP and Quality Management Systems (QMS)

Benefits & Relocation Assistance:

• 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!

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Masis Staffing is committed to providing a workplace free of discrimination, harassment, and retaliation. We are an equal opportunity employer. Applicants, employees, and former employees are protected from employment discrimination based on race, color, religion, sex (including pregnancy, sexual orientation or transgender status), national origin, age (40 or older), veteran status, disability and genetic information (including family medical history).