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Fda Auditor Jobs (NOW HIRING)

Astrix Inc

QA Auditor (FDA/GMP/21 CFR)

Lancaster, SC · On-site

... 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

Collabera

Auditor

Mundelein, IL · On-site

$28 - $30/hr

We are looking for a Quality Auditor to perform detailed audits of product complaint files, adverse event documentation, and quality records to ensure compliance with FDA regulations, internal ...

synergy

QA Lead Auditor

Dallas, TX · Hybrid

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 ...

synergy

QA Lead Auditor

Dallas, TX · On-site

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 ...

synergy

QA Lead Auditor

Dallas, TX · On-site

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 ...

Collabera

Quality Auditor

Mundelein, IL · On-site

$25 - $30/hr

... FDA Quality System Regulations (21 CFR Part 820) and/or ISO 13485 Hands-on experience conducting quality audits of regulated documentation (product complaints, adverse events, CAPAs, or similar)

Staffing Synergies

Quality Auditor

Edison, NJ

$18/hr

Quality Auditor Location: Edison, NJ Pay: $18/hr Shift: 1st shift - 6:00am-2:45pm 2nd shift - 3 ... Perform quality inspections on production lines to ensure compliance with FDA, cGMP, SOPs, and ...

Actalent

Quality Assurance Auditor

Boston, MA

Knowledge of FDA regulations 21 CFR Parts 210, 211, and 507, as well as Dietary Supplement Regulations 21 CFR 111, is preferred. * ASQ Certified Quality Auditor (CQA) certification is preferred.

Staffing Synergies

Quality Auditor

Edison, NJ

$18/hr

Quality Auditor Location: Edison, NJ Pay: $18/hr Shift: 1st shift - 6:00am-2:45pm 2nd shift - 3 ... Perform quality inspections on production lines to ensure compliance with FDA, cGMP, SOPs, and ...

Staffing Synergies

Quality Auditor

Edison, NJ

$18/hr

Quality Auditor Location: Edison, NJ Pay: $18/hr Shift: 1st shift - 6:00am-2:45pm 2nd shift - 3 ... Perform quality inspections on production lines to ensure compliance with FDA, cGMP, SOPs, and ...

Staffing Synergies

Quality Auditor

Edison, OH

$18/hr

Quality Auditor Location: Edison, NJ Pay: $18/hr Shift: 1st shift - 6:00am-2:45pm 2nd shift - 3 ... Perform quality inspections on production lines to ensure compliance with FDA, cGMP, SOPs, and ...

Staffing Synergies

Quality Auditor

Edison, NJ

$18/hr

Quality Auditor Location: Edison, NJ Pay: $18/hr Shift: 1st shift - 6:00am-2:45pm 2nd shift - 3 ... Perform quality inspections on production lines to ensure compliance with FDA, cGMP, SOPs, and ...

Staffing Synergies

Quality Auditor

Edison, NJ

$18/hr

Quality Auditor Location: Edison, NJ Pay: $18/hr Shift: 1st shift - 6:00am-2:45pm 2nd shift - 3 ... Perform quality inspections on production lines to ensure compliance with FDA, cGMP, SOPs, and ...

Collabera

Quality Auditor

Mundelein, IL · On-site

$25 - $30/hr

Job Title: Quality Auditor Locations: Mundelein, IL Schedule: Hybrid Duration: 3 - 6 months ... FDA Quality System Regulations (21 CFR Part 820) and/or ISO 13485 Excellent written and verbal ...

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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 Jul 15, 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.

How much does an FDA auditor get paid?

An FDA auditor's salary typically ranges from $60,000 to $100,000 annually, depending on experience, location, and employer. Senior auditors or those with specialized certifications may earn higher wages, and the role often requires knowledge of regulatory standards and inspection procedures.

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 is the highest paying job at the FDA?

The highest paying jobs at the FDA are typically senior leadership roles such as the Commissioner of Food and Drugs or Deputy Commissioner, as well as senior scientific and regulatory positions like Directors or Chief Scientists. These roles often require advanced degrees, extensive experience, and specialized expertise, and they can earn salaries exceeding $200,000 annually, including bonuses and benefits.

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.

Is it hard to get hired by the FDA?

Getting hired as an FDA auditor can be competitive due to the specialized skills and qualifications required, such as a background in science, healthcare, or regulatory affairs, along with relevant certifications. Candidates often need experience in quality assurance, compliance, or inspection roles, and the hiring process may involve multiple interviews and background checks.

How do you become an FDA auditor?

To become an FDA auditor, candidates typically need a background in life sciences, healthcare, or quality assurance, along with experience in regulatory compliance or manufacturing. Earning certifications such as Certified Quality Auditor (CQA) or attending FDA-specific training programs can enhance qualifications. Auditors often need to understand FDA regulations, Good Manufacturing Practices (GMP), and have strong inspection skills.

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.

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Fda Auditor jobs near you
Infographic showing various Fda Auditor job openings in the United States as of July 2026, with employment types broken down into 88% Full Time, 6% Part Time, and 6% Nights. Highlights an 100% In-person job distribution, with an average salary of $76,256 per year, or $36.7 per hour.
QA Auditor (FDA/GMP/21 CFR)

QA Auditor (FDA/GMP/21 CFR)

Astrix Inc

Lancaster, SC • On-site

Full-time

Re-posted 28 days ago

Job description

Job Title: Quality Assurance Auditor
Location: Lancaster, SC
Schedule: Monday-Friday, 8:30 AM - 5:00 PM
Salary: $70,000 - $95,000 + discretionary bonus (up to 12%, prorated first year)
Relocation: Full relocation package available (including temporary housing, moving/storage, and paid site visits)
Position Overview
We are seeking an experienced Quality Assurance Auditor to join our team in Lancaster, SC. This role will report directly to the Supplier Quality & Compliance Manager and will play a critical role in supporting and expanding internal and external audit capabilities across suppliers, CMOs, and contract laboratories.
This is a highly visible position within QA, responsible for ensuring compliance with FDA regulations and strengthening supplier quality programs.
Key Responsibilities
  • Plan, schedule, and execute internal and external audits to ensure compliance with cGMP and applicable FDA regulations
  • Perform supplier/vendor/CMO audits and maintain the Approved Vendor List within the QMS (Qualityze)
  • Manage the Supplier Corrective Action Request (SCAR) program and ensure timely closure of audit findings
  • Assess audit findings, determine risk levels, and drive effective corrective and preventive actions (CAPA)
  • Maintain all audit, vendor, and compliance documentation within the QMS
  • Support and enhance the internal compliance program and audit processes
  • Track, analyze, and report audit metrics to QA leadership
  • Partner cross-functionally to ensure alignment on quality and compliance expectations
  • Support regulatory inspection readiness and internal training initiatives
  • Travel to supplier sites (domestic and occasional international) for audits

Qualifications
  • Bachelor's degree (BS/BA) in a scientific or technical field
  • 5+ years of QA auditing experience in a cGMP-regulated environment
  • 5+ years of external supplier/vendor 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
  • Experience managing supplier quality programs, vendor qualification, and audit documentation
  • Familiarity with QMS systems (Qualityze preferred) and SAP
  • Proficient in Microsoft Office

Preferred Qualifications
  • ASQ Certified Quality Auditor (CQA) certification
  • Experience auditing CMOs and contract laboratories

Additional Requirements
  • Ability to travel 20-30% for domestic supplier audits (with occasional international travel)
  • Ability to work in manufacturing and cleanroom environments, including use of required PPE
  • Strong communication skills and ability to work across all levels of the organization

Why Join Us?
  • High-impact role supporting a growing QA function
  • Strong leadership and collaborative team environment
  • Competitive compensation + bonus potential
  • Comprehensive relocation support
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