More jobs:
Quality Assurance Auditor | cGMP | FDA
Job in
Lancaster, Lancaster County, South Carolina, 29721, USA
Listed on 2026-07-23
Listing for:
Masis Professional Group
Full Time
position Listed on 2026-07-23
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, QA Specialist - Analyst/Manager, Quality Control - QC Analysts/Managers
Job Description & How to Apply Below
Location: Charlotte, NC (30–45 minutes commute)
Compensation: $85k–$100k + discretionary bonus potential up to 12% of YTD earnings.
Eligibility: US Citizens or Green Card Holders only. No C2C.
Company: Join an industry-leading health and wellness manufacturer dedicated to improving lives through science, innovation, and uncompromising quality.
Job Description: 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.
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 corrective action 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.
- Minimum 5 years of Quality Assurance auditing experience in a cGMP environment with a minimum of 5 years of external vendor/supplier compliance auditing experience within an FDA regulated industry.
- Experience with 21 CFR Parts 210, 211, and 21 CFR 111.
- ASQ Certified Auditor (CQA) Certification is preferred.
- Proficient in computer software applications including MS Office suite.
- Willingness to travel 20–30% for domestic audits; international travel may be required.
- 45 days of fully furnished temporary housing.
- $5,000 relocation stipend.
- Stipend paid for area exploration.
- 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.
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