QA Auditor

Base pay range $70,000.00/yr - $95,000.00/yr 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 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 Seniority level Mid-Senior level Employment type Contract Job function Accounting/Auditing Industries Pharmaceutical Manufacturing #J-18808-Ljbffr