QA Auditor

Location: Lancaster, SC
Department: Quality Assurance
Job Type: Full-time

Position Summary

The Quality Assurance Auditor reports to the Supplier Quality and Compliance Manager and is responsible for developing and maintaining a robust internal compliance program. This role ensures adherence to applicable regulations through internal and external audits, vendor oversight, and corrective action management.

Key Responsibilities

• Plan, schedule, and execute internal and external audits to assess regulatory compliance.
• Audit external suppliers (CMOs) and manage the vendor qualification program, including maintaining the Approved Vendor List in a QMS platform.
• Oversee external vendors conducting international audits.
• Manage the supplier corrective action request (SCAR) program.
• Maintain audit, vendor, and supplier documentation within a QMS (e.g., Qualityze).
• Assess risk levels of audit findings and ensure timely and effective corrective and preventive actions.
• Develop and implement performance tracking systems and compliance reporting.
• Support CAPA implementation where applicable.
• Train internal departments on quality and compliance expectations.
• Identify and prioritize internal audit areas based on risk and develop or improve processes to mitigate non-compliance.
• Support regulatory inspection readiness and training.
• Provide cross-functional support to the Quality Assurance team.
• Report audit metrics to QA and department leadership.
• Collaborate with Contract Manufacturing Organizations on product development, investigations, and CAPAs.
• Utilize QA functions in SAP.
• Perform additional duties as needed to support QA and organizational goals.

Requirements

Minimum Qualifications

• Minimum 5 years of QA auditing experience in a cGMP-regulated environment, including 5 years of external vendor/supplier auditing within an FDA-regulated industry.
• Strong knowledge of 21 CFR Parts 210, 211, 507, and Dietary Supplement Regulations (21 CFR 111).
• ASQ Certified Quality Auditor (CQA) preferred.
• Proficiency in Microsoft Office and QMS platforms.
• Ability to work in manufacturing and cleanroom environments, including wearing required PPE.
• Willingness to travel 20-30% domestically (international travel may be required).

Education

• B.A. or B.S. in a Science or Technical field required.

Supervisory Responsibilities

• None