Supplier Quality Auditor

RevanceJohnson City, TN
Onsite

About The Position

The Supplier Quality Auditor is responsible for executing risk-based GMP audit programs supporting OTC and cosmetic operations. They will ensure compliance with 21 CFR 210/211, ISO 22716, and internal quality systems. They will lead supplier, CMO, and internal audits, including routine, for-cause, and surveillance activities. They will support inspection readiness and continuous improvement activities.

Requirements

  • Bachelor’s degree & 3-5 years’ directly related experience, or an equivalent combination of education and experience.
  • Travel up to 50%.
  • 3-5 years’ GMP Quality/Auditing experience (OTC, cosmetic, or pharmaceutical).
  • Strong knowledge of GMP regulations and quality systems.
  • Effective audit execution and technical writing skills.
  • Strong analytical and problem-solving abilities.
  • Excellent communication and cross-functional collaboration skills.

Responsibilities

  • Execute risk-based GMP audits (supplier, CMO, internal, for-cause, surveillance).
  • Perform gap assessments and compliance evaluations aligned with regulatory standards.
  • Identify, document, and assess audit findings with appropriate risk ratings.
  • Drive and track CAPA, SCAR, and deviation resolution.
  • Support inspection readiness, including mock audits and audit hosting activities.
  • Provide cross-functional GMP and quality compliance support.
  • Support change control, document control, and training processes.
  • Ensure compliance with QMS requirements.
  • Understand tracking and trending data for Quality Compliance.
  • Analyze and trend quality data to support continuous improvement.

Benefits

  • Competitive Compensation including base salary and annual performance bonus.
  • Flexible PTO, holidays, and parental leave.
  • Generous healthcare benefits, HSA match, 401k match, employer paid life and disability insurance, pet insurance, wellness discounts and much more!
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