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Fda Auditor Jobs (NOW HIRING)

... auditing experience within an FDA-regulated industry * Strong knowledge of 21 CFR Parts 210, 211, 507, and 111 (dietary supplements) * Hands-on experience with both internal and external audits

QA Lead Auditor - With Previous FDA Audit Experience. This position will be responsible for planning and conducting audit procedures, including identifying and defining audit issues, developing audit ...

QA Lead Auditor - With Previous FDA Audit Experience. This position will be responsible for planning and conducting audit procedures, including identifying and defining audit issues, developing audit ...

QA Lead Auditor - With Previous FDA Audit Experience. This position will be responsible for planning and conducting audit procedures, including identifying and defining audit issues, developing audit ...

QA Lead Auditor - With Previous FDA Audit Experience. This position will be responsible for planning and conducting audit procedures, including identifying and defining audit issues, developing audit ...

S. Food and Drug Administration (FDA) and Health Canada. Why This Role Matters We are looking for a meticulous, audit-driven Senior Quality Auditor to join our Quality team. In this role, you will ...

Senior Quality Auditor

Tucson, AZ ยท On-site

$80K - $110K/yr

S. Food and Drug Administration (FDA) and Health Canada. Why This Role Matters We are looking for a meticulous, audit-driven Senior Quality Auditor to join our Quality team. In this role, you will ...

Senior Quality Auditor

Tucson, AZ ยท On-site

$80K - $110K/yr

S. Food and Drug Administration (FDA) and Health Canada. Why This Role Matters We are looking for a meticulous, audit-driven Senior Quality Auditor to join our Quality team. In this role, you will ...

Senior Compliance Auditor I

Abbott, TX ยท On-site

$70K - $87K/yr

Evaluate compliance with global regulations including FDA 21 CFR Part 11, FDA 21 CFR Part 820, ISO ... Lead auditor certificate for Quality System audits is desirable. Required Skills * In-depth ...

Senior Compliance Auditor I

Abbott, TX

$70K - $87K/yr

Evaluate compliance with global regulations including FDA 21 CFR Part 11, FDA 21 CFR Part 820, ISO ... Lead auditor certificate for Quality System audits is desirable. Required Skills * In-depth ...

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Fda Auditor information

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$33K

$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:
What states have the most Fda Auditor jobs? States with the most job openings for Fda Auditor jobs include:
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.
GCP/GMP Auditor - Former FDA / FDA Inspection Experience (Midwest USA)

GCP/GMP Auditor - Former FDA / FDA Inspection Experience (Midwest USA)

SQA Services

Indianapolis, IN โ€ข On-site

$4K - $5K/wk

Temporary

Posted 9 days ago


Job description

For more than 30 years, SQA Services has been a leader in providing managed supplier quality services - including audits, assessments, corrective actions, inspections, remediation, and engineering support - to manufacturers across regulated industries. We deploy experienced auditors across the United States and in over 90 countries to support client and supplier sites on demand.
SQA Services is seeking a senior auditor with former FDA experience and direct FDA inspection exposure to support a 4-day mock FDA Pre-Approval Inspection (PAI) in Indianapolis, Indiana.
This engagement will simulate an FDA inspection environment, requiring an auditor who understands FDA expectations, inspection readiness, and compliance risks across GCP and GMP operations. The auditor will play a key role in assessing readiness and identifying gaps prior to a regulatory inspection.
Auditors located in the Midwest U.S. or willing to travel are preferred.
Key Responsibilities
  • Conduct a mock FDA Pre-Approval Inspection (PAI) in alignment with FDA expectations
  • Evaluate compliance to Good Clinical Practices (GCP) and 21 CFR 210/211 (GMP)
  • Assess inspection readiness, quality systems, and documentation practices
  • Identify compliance gaps and potential regulatory risks
  • Provide detailed audit findings and recommendations
  • Prepare and deliver audit reports per client and SQA standards
  • Communicate observations clearly to stakeholders and leadership

Required Qualifications
  • Direct experience supporting/hosting FDA inspections
  • Experience conducting mock FDA inspections or PAI readiness assessments
  • Strong experience auditing to GCP and 21 CFR 210/211 (GMP)
  • Proven ability to conduct regulatory-style audits (PAI readiness or mock FDA inspections)
  • Strong understanding of FDA inspection processes and expectations
  • Excellent reporting, communication, and stakeholder engagement skills
  • Willingness to travel to Indianapolis, IN for a 4-day audit

Preferred Qualifications
  • Background in clinical and commercial pharmaceutical environments
  • Experience supporting high-visibility or regulatory-critical audits
  • Located in the Midwest U.S.

$4,500 - $5,000 a week
4-day audit Pay Rate inclusive of preparation, travel, audit execution, reporting, and follow-up.
Travel expenses reimbursed at cost with receipts per SQA travel policy.
Note:
SQA is an Equal Opportunity Employer. Employment is based on merit and qualifications, and is not influenced by race, color, religion, gender, national origin, veteran status, disability, age, sexual orientation, gender identity, marital status, or any other legally protected status.
This position requires access to ITAR-controlled technical data and/or defense articles. As such, the candidate must be a U.S. citizen or U.S. lawful permanent resident (green card holder) to comply with the International Traffic in Arms Regulations (ITAR). Applicants who do not meet these criteria will not be considered for this role.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.