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
FAQs
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