Supplier Quality Auditor

Reposted 24 Days Ago
Be an Early Applicant
Johnson City, TN, USA
In-Office
Mid level
Healthtech • Biotech
The Role
The Supplier Quality Auditor conducts GMP audits for suppliers and CMOs, ensuring compliance with regulatory standards and supporting quality improvement initiatives.
Summary Generated by Built In

Job Summary:

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.


Reporting to:
    Quality Assurance Manager, CMOs
Location:             Johnson City, TN - onsite


Responsibilities/Essential Duties:

  • 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.

 
Basic Qualifications:

  • Bachelor’s degree & 3-5 years’ directly related experience, or an equivalent combination of education and experience.
  • Travel up to 50%.


Preferred Qualifications:

  • 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.


Company Summary:

Crown is a proud member of the Revance Portfolio of skincare offerings. Revance is a global company developing, producing, and distributing industry-leading, differentiated products across aesthetics, skincare, and therapeutics. Revance drives innovation beyond convention to offer treatment options for individuals across generations. The Company’s vision is to redefine excellence in aesthetics, skincare, and therapeutics through science-powered innovation, with an unwavering commitment to its providers, patients, and consumers. Revance’s award-winning products are the result of robust research and development, a cornerstone for the Company, driven by renowned scientists. For more information about Revance, please visit us at www.revance.com.
What Revance invests in you:

  • 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!

Work Environment & Physical Requirements

This position requires extended periods of standing and walking on a manufacturing floor environment. Protective equipment (safety glasses, hearing protection, gowning) must be worn as required. The role operates in a temperature-controlled pharmaceutical manufacturing facility. Occasional lifting of up to 30 lbs may be required. Must be available to respond to critical shift issues outside of scheduled hours on an as-needed basis.


This section of the job description is required by the American with Disability Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a “qualified individual with a disability” in all aspects of the employment relationship. A “qualified individual with a disability” is “an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job.”

Revance is an Equal Opportunity employer. All qualified applicants will receive consideration for employment based on merit, without regard to race, color, religion, sex, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.


Skills Required

  • Bachelor's degree
  • 3-5 years' directly related experience
  • Strong knowledge of GMP regulations
  • Effective audit execution skills
  • Strong analytical skills
  • Excellent communication skills
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The Company
HQ: Nashville, Tennessee
663 Employees

What We Do

Revance is a biotechnology company setting the new standard in healthcare with innovative aesthetic and therapeutic offerings that elevate patient and physician experiences

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