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Fda Auditor Jobs (NOW HIRING)

Astrix Inc

Quality Assurance Auditor

Charlotte, NC · On-site

Bachelor's degree in a scientific field * 5 years of QA auditing experience in a cGMP environment & external vendor/supplier compliance within an FDA regulated industry. * Knowledge of Regulations ...

Getinge

Principal Quality Internal Auditor

Wayne, NJ · On-site

$155K - $165K/yr

The auditor brings expert knowledge from prior roles leading audits and driving compliance ... Participate in and lead FDA and Notified Body audits, including audit planning, execution ...

Getinge

Principal Quality Internal Auditor

Wayne, NJ · On-site

$155K - $165K/yr

The auditor brings expert knowledge from prior roles leading audits and driving compliance ... Participate in and lead FDA and Notified Body audits, including audit planning, execution ...

Boston Scientific

Senior QA Auditor

Valencia, CA

... the FDA and notified bodies. The position requires deep knowledge of quality systems within the ... ISO 13485 Lead Auditor certification is required. * Minimum of five (5) years of experience in the ...

Boston Scientific

Senior QA Auditor

Valencia, CA

... the FDA and notified bodies. The position requires deep knowledge of quality systems within the ... ISO 13485 Lead Auditor certification is required. * Minimum of five (5) years of experience in the ...

Boston Scientific

Senior QA Auditor

Valencia, CA · On-site

... the FDA and notified bodies. The position requires deep knowledge of quality systems within the ... ISO 13485 Lead Auditor certification is required. * Minimum of five (5) years of experience in the ...

Boston Scientific

Senior QA Auditor

Valencia, CA

... the FDA and notified bodies. The position requires deep knowledge of quality systems within the ... ISO 13485 Lead Auditor certification is required. * Minimum of five (5) years of experience in the ...

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Fda Auditor information

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$76.3K

$121.5K

How much do fda auditor jobs pay per year?

As of Jun 9, 2026, the average yearly pay for fda auditor in the United States is $76,256.00, according to ZipRecruiter salary data. Most workers in this role earn between $53,500.00 and $98,500.00 per year, depending on experience, location, and employer.

What is an FDA Auditor job?

An FDA Auditor is responsible for inspecting facilities, processes, and documentation to ensure compliance with U.S. Food and Drug Administration (FDA) regulations. They review manufacturing practices, quality control systems, and regulatory filings for industries such as pharmaceuticals, medical devices, and food production. FDA Auditors may work for the FDA or for companies preparing for FDA inspections. Their role helps ensure public safety by verifying that products meet legal and quality standards.

What are the key skills and qualifications needed to thrive in the Fda Auditor position, and why are they important?

To thrive as an FDA Auditor, you need a strong background in life sciences, regulatory compliance, and audit methodologies, usually supported by a relevant degree and professional certifications such as RAC or CQA. Familiarity with FDA regulations (such as 21 CFR), electronic quality management systems (eQMS), and audit management tools is essential. Attention to detail, critical thinking, and strong communication skills help auditors navigate complex regulatory settings and interact effectively with stakeholders. These competencies are crucial for ensuring companies meet rigorous FDA standards and maintain regulatory compliance.

What are the primary challenges FDA Auditors face during compliance inspections?

FDA Auditors often encounter challenges such as interpreting complex and evolving regulatory guidelines, managing on-site audits in diverse environments, and reviewing extensive documentation under tight timeframes. They must adapt quickly to various industry settings, handle potentially uncooperative stakeholders, and maintain objectivity throughout their evaluations. Successfully overcoming these challenges requires resilience, up-to-date regulatory knowledge, and excellent people skills. These hurdles are a vital part of ensuring public health and safety by holding organizations to the highest standards of compliance.

More about Fda Auditor jobs
What cities are hiring for Fda Auditor jobs? Cities with the most Fda Auditor job openings:
What are the most commonly searched types of Fda Auditor jobs? The most popular types of Fda Auditor jobs are:
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Fda Auditor jobs near you
Infographic showing various Fda Auditor job openings in the United States as of May 2026, with employment types broken down into 77% Full Time, 21% Part Time, and 2% Contract. Highlights an 87% Physical, 6% Hybrid, and 7% Remote job distribution, with an average salary of $76,256 per year, or $36.7 per hour.

Radio Pharmaceuticals QA Auditor

BioHire Health

Paramus, NJ

$40 - $67/hr

Contractor

Posted 16 days ago

Job description

Job Summary:

The RPT QA Auditor is responsible for planning, conducting, and reporting on internal and external audits to ensure compliance with cGMP, regulatory requirements, and company quality standards. This role supports the Pharmaceutical Quality System (PQS) by identifying gaps, recommending corrective actions, and driving continuous improvement across manufacturing, testing, and distribution processes.

Key Responsibilities:

  • Conduct routine, for-cause, and risk-based audits of internal processes, RPT CMOs, and suppliers.
  • Prepare detailed audit plans, checklists, and schedules.
  • Ensure adherence to FDA, EMA, ICH, and other applicable regulatory guidelines.
  • Review and approve deviations, CAPAs, and change controls.
  • Document audit observations and issue formal audit reports.
  • Track and verify implementation of corrective and preventive actions (CAPAs).
  • Provide guidance on compliance requirements and audit readiness.
  • Support regulatory inspections and customer audits.
  • Identify systemic issues and recommend process improvements.
  • Stay updated on evolving regulatory requirements and industry best practices.

Qualifications:

  • Bachelor's degree in Life Sciences, Pharmacy, or related field.
  • 3-5 years in Radio Pharmaceuticals (Must Have), with at least 2 years in auditing.
  • Strong knowledge of RPT cGMP, GDP, and global regulatory requirements.
  • Excellent attention to detail and analytical skills.
  • Strong communication and report-writing abilities.
  • Ability to travel (up to 10%) for audits.

Preferred Certifications:

  • ASQ Certified Quality Auditor (CQA)
  • ISO 9001 Lead Auditor
  • GCP/GMP auditing certifications
Employment Type: CONTRACTOR

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