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Fda Auditor Jobs (NOW HIRING)

Actalent

QA Auditor

Syracuse, NY

Job Title: QA Auditor The QA Auditor performs in-house line audits of pharmaceutical filling and ... Experience in Quality Assurance or Manufacturing in an FDA-regulated pharmaceutical environment is ...

Ferrero

Packaging FSQ Auditor

Chicago, IL · On-site

$96K - $154K/yr

Business Experience: • 8+ years of Packaging experience • Direct experience with Packaging regulations in North America (FDA & CFIA) • Experience in leading packaging audits (auditor ...

Ferrero

Packaging FSQ Auditor

Chicago, IL · Hybrid

$96K - $154K/yr

Business Experience: • 8+ years of Packaging experience • Direct experience with Packaging regulations in North America (FDA & CFIA) • Experience in leading packaging audits (auditor ...

Online Labels Group

Quality Control Auditor

Sanford, FL · On-site

$17 - $20/hr

Knowledge of Quality Management Systems (ISO,FDA, BSI) is preferred. * Knowledge of Flexographic and/or digital printing or previous experience as a Quality Auditor is preferred. Pay: $17.00-20.00 ...

Online Labels Group

Quality Control Auditor

Sanford, FL · On-site

$17 - $20/hr

Knowledge of Quality Management Systems (ISO,FDA, BSI) is preferred. * Knowledge of Flexographic and/or digital printing or previous experience as a Quality Auditor is preferred. Pay: $17.00-20.00 ...

Online Labels

Quality Control Auditor

Sanford, FL · On-site

$17 - $20/hr

Knowledge of Quality Management Systems (ISO,FDA, BSI) is preferred. * Knowledge of Flexographic and/or digital printing or previous experience as a Quality Auditor is preferred. Pay: $17.00-20.00 ...

Intertek

QA Auditor II

Whitehouse, NJ · On-site

$70K - $95K/yr

QA Auditor II - Whitehouse, NJ Intertek is searching for a QA Auditor II to join our Chemicals ... Ensure compliance with US FDA, US DEA and EMA regulations * Follow all SOPs and Safety Guidelines ...

Merican

GCP Auditor, Quality Assurance

Paramus, NJ · On-site

Job Title: GCP Auditor, Quality Assurance Location: Paramus, NJ, 07652 Job Type: Temporary ... FDA regs, GCP, etc.). * Collaborate with clinical sourcing, supplier quality and clinical ...

SQA Services

Quality Auditor - Pharmaceutical

Chicago, IL · Remote

$1.3K/day

Utilize your regulatory knowledge of various standards from ISO, CFR, FDA, etc... * Respond to the ... Has been the lead auditor in at least 10 audits * Direct audit experience to 21 CFR part 210/211 ...

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Fda Auditor information

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$76.3K

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How much do fda auditor jobs pay per year?

As of Aug 6, 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?

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 as an FDA auditor?

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 do FDA auditors make?

FDA auditors typically earn a salary that ranges from $60,000 to $100,000 annually, depending on experience, location, and employer. They may also receive benefits such as health insurance, paid time off, and overtime pay, especially when conducting inspections or audits. Salaries can vary based on certifications, such as Certified Quality Auditor (CQA), and the complexity of the audits performed.

How to become an FDA auditor?

To become an FDA auditor, candidates typically need a bachelor's degree in a relevant field such as life sciences, chemistry, or pharmacy, along with experience in quality assurance or regulatory compliance. Professional certifications like Certified Quality Auditor (CQA) or training in Good Manufacturing Practices (GMP) are also valuable. Strong attention to detail, knowledge of FDA regulations, and auditing skills are essential for success in this role.

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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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 July 2026, with employment types broken down into 89% Full Time, 8% Part Time, 2% Contract, and 1% Nights. 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.

In Process Quality Assurance Auditor

TekSky

Greenville, SC • On-site

Full-time

Posted 25 days ago

Job description

Job Summary
The In Process Quality Assurance Auditor ensures consistent product quality through independent inspection in process testing, verification and auditing of pharmaceutical drugs during manufacturing and packaging within a cGMP-regulated pharmaceutical manufacturing environment.
This position provides intermediate-level Quality Assurance support across manufacturing, warehousing and packaging operations. The In Process Quality Assurance Auditor applies critical thinking, analytical reasoning, and sound judgment to evaluate data, identify deviations, and ensure compliance with internal procedures and regulatory requirements (FDA, DEA).
Essential Duties And Responsibilities
Quality Assurance Operations
  • Promote and ensure compliance with current Good Manufacturing Practices (cGMPs) and all applicable regulatory standards.
  • Independently perform in-process inspections throughout manufacturing and packaging operations to verify conformance to specifications.
  • Conduct verification of production operations and environmental conditions prior to line clearance and batch initiation.
  • Perform in-process testing (pH, specific gravity, etc.) and assay calculations for compounding operations.
Review batch records, logbooks, and associated documentation for completeness and compliance as the process is in production ; verify data accuracy and documentation integrity. Identify out of trends or non conformances from documented data or auditing on the line from in process testing results , review of label print and application, DSCSA serialization/aggregation , downtime activities, and proactively communicate to put in corrective actions prior to the product being removed from the area. Record inspection results and maintain accurate data in quality systems (SAP, WMS, and other databases).
  • Identify, segregate, and document non-conforming events on the process line, and halt the processing if critical compliance activities are identified. Ie, product spills, equipment set up incorrectly, label print incorrect, mixed components on the line,
  • Immediately escalate non conformance or observations to management for direction
Initiate non conformances in TrackWise system and assist in investigations Apply critical thinking to evaluate quality data, assess deviations, and determine appropriate actions or escalation.
  • Support Process Issues (PIs) and Corrective and Preventive Actions (CAPAs) by providing detailed, factual information.
  • Collaborate with manufacturing and packaging personnel to resolve quality issues and ensure adherence to quality standards.
  • Participate in continuous improvement activities to enhance product quality and operational efficiency.
  • Conduct packaging room and line clearance inspections prior to production start-up.
  • Verify reconciliation of components after batch completion and ensure proper documentation and return to inventory.
  • Exercise judgment and problem-solving skills to identify potential quality risks in packaging operations.
Continuous Improvement and Compliance
  • Support the development and revision of SOPs, Work Instructions (WIs), and related quality documents.
  • Assist with internal audits and data collection for quality reporting.
  • Provide on-the-job training to QA Inspector I or new team members as assigned.
  • Maintain up-to-date knowledge of cGMPs, regulatory requirements, and company quality policies.
Education And Experience
  • High school diploma or GED required; associate degree in a scientific or technical discipline preferred.
  • Minimum 2 years of Quality Assurance or Quality Control experience in a pharmaceutical or regulated manufacturing environment required.
  • Demonstrated understanding of FDA/DEA regulations, cGMP compliance, and documentation practices.
  • Proficiency with Microsoft Office (Word, Excel, Outlook) and experience with SAP or equivalent ERP/WMS systems preferred.
  • Strong mathematical aptitude and ability to perform precise calculations and data entry.
Knowledge, Skills & Abilities
  • Advanced critical thinking and analytical reasoning skills - able to evaluate data, identify trends, and make quality-based decisions.
  • Strong attention to detail, accuracy, and documentation discipline.
  • Excellent communication skills, both verbal and written.
  • Ability to manage multiple priorities and work effectively under minimal supervision.
  • Strong interpersonal skills with the ability to work collaboratively across departments.
  • Self-motivated, dependable, and demonstrates high ethical and professional standards.
Physical Requirements & Working Conditions
  • Regularly required to stand, walk, sit, talk, and hear.
  • Occasionally required to climb, balance, stoop, kneel, crouch, or crawl.
  • Must be able to lift up to 50 lbs.
  • Visual requirements include close, distance, color, and depth perception.
  • Work is performed in both office and manufacturing environments with exposure to moving mechanical parts and occasional contact with chemicals.
  • Must comply with gowning and cleanroom entry requirements.
  • Moderate noise level typical of manufacturing environments.

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