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Quality Assurance Auditor | cGMP | FDA

Job in Lancaster, Lancaster County, South Carolina, 29721, USA
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
Salary/Wage Range or Industry Benchmark: 85000 - 100000 USD Yearly USD 85000.00 100000.00 YEAR
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.
Qualifications
  • 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.
Benefits
  • 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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