Quality Assurance Auditor - Supplier Compliance

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

Benefits offered by this job

Discretionary bonus up to 12%

Job summary

Masis Professional Group is seeking a Quality Assurance Auditor in the Charlotte, NC area to strengthen internal compliance and supplier audits. The role reports to the Supplier Quality and Compliance Manager and requires leading internal and external audits, and promoting CAPA processes.

Qualified candidates have at least 5 years in QA auditing in cGMP, audit experience with vendors, familiarity with 21 CFR parts, and ASQ CQA preferred. Travel up to 30% is expected; SAP/QMS experience is a plus.

Qualifications

• Minimum 5 years of QA auditing in a cGMP environment.
• 5 years external vendor/supplier compliance auditing in FDA-regulated industry.
• Regulatory knowledge of 21 CFR Part 210/211/507 and 21 CFR 111 Dietary Supplements regs.

Responsibilities

• Plan, schedule, and conduct internal and external audits.
• Audit suppliers and contract manufacturers (CMOs) and maintain vendor qualification programs.
• Manage supplier corrective actions (SCARs) and verify CAPA effectiveness.
• Monitor and report audit and compliance metrics to management.
• Support regulatory inspection readiness and ongoing compliance initiatives.

Skills

Quality Assurance auditing

MS Office

Audit planning

Travel readiness

Education

ASQ Certified Auditor (CQA) certification preferred

Tools

SAP

Quality Management System (QMS) software

Job description

Masis Professional Group is seeking a Quality Assurance Auditor in the Charlotte, NC area to strengthen internal compliance and supplier audits. The role reports to the Supplier Quality and Compliance Manager and requires leading internal and external audits, and promoting CAPA processes.

Qualified candidates have at least 5 years in QA auditing in cGMP, audit experience with vendors, familiarity with 21 CFR parts, and ASQ CQA preferred. Travel up to 30% is expected; SAP/QMS experience is a plus.