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Fda Auditor Jobs in Indiana (NOW HIRING)

Elanco

Global Quality Auditor Lead

Indianapolis, IN · Hybrid

Demonstrated success in auditing aseptic or sterile manufacturing platforms under FDA, EMA, or similar regulatory oversight * Experience leading or contributing to quality improvement initiatives ...

SQA Services

Quality Auditor - Pharmaceutical

Warren, IN · 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 ...

SQA Services

Quality Auditor - Pharmaceutical

Carmel, IN · 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 ...

Elanco

R&D Quality Assurance Auditor

Indianapolis, IN · Hybrid

A minimum of 5-10 years of experience providing quality oversight or auditing of veterinary clinical and/or non-clinical safety studies regulated by FDA, EPA, USDA, or OECD. * Top Skills: Strong ...

Inotiv

Quality Assurance Auditor III

West Lafayette, IN · On-site

Demonstrate solid understanding of application and interpretation of FDA and EPA GLPs as well as ... Three to five years of experience in a GLP preferably with 1-3 or more years of auditing experience ...

INCOG BioPharma Services

Audit Specialist

Fishers, IN · On-site

Knowledge of US and international regulations, guidelines, and other compendia (e.g., FDA, EMA, ICH, PIC/S) * Quality auditing certification (e.g., ASQ Certified Quality Auditor (CQA) or equivalent ...

INCOG BioPharma Services

Audit Specialist

Fishers, IN · On-site

Knowledge of US and international regulations, guidelines, and other compendia (e.g., FDA, EMA, ICH, PIC/S) * Quality auditing certification (e.g., ASQ Certified Quality Auditor (CQA) or equivalent ...

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Fda Auditor information

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$31.4K

$72.6K

$115.6K

How much do fda auditor jobs pay per year?

As of Jul 26, 2026, the average yearly pay for fda auditor in Indiana is $72,562.00, according to ZipRecruiter salary data. Most workers in this role earn between $50,900.00 and $93,700.00 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.

What are popular job titles related to Fda Auditor jobs in Indiana? For Fda Auditor jobs in Indiana, the most frequently searched job titles are:
What job categories do people searching Fda Auditor jobs in Indiana look for? The top searched job categories for Fda Auditor jobs in Indiana are:
Fda Auditor jobs near you
Infographic showing various Fda Auditor job openings in Indiana as of July 2026, with employment types broken down into 86% Full Time, 10% Part Time, 3% Contract, and 1% Nights. Highlights an 89% Physical, 5% Hybrid, and 6% Remote job distribution, with an average salary of $72,562 per year, or $34.9 per hour.
Global Quality Auditor Lead

Global Quality Auditor Lead

Elanco Animal Health Incorporated

Indianapolis, IN • On-site

Full-time

Retirement, PTO

Posted 3 days ago

Elanco rating

7.8

Company rating: 7.8 out of 10

Based on 25 frontline employees who took The Breakroom Quiz

51st of 86 rated pharmaceutical

Job description

At Elanco (NYSE: ELAN) - it all starts with animals!
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose - all to Go Beyond for Animals, Customers, Society and Our People.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals' lives better makes life better - join our team today!
Your Role: Global Quality Auditor Lead
As a Global Quality Auditor Lead, you will be part of the Elanco Global Quality Compliance and Auditing (EGQCA) organization, supporting Elanco Animal Health through internal and external audits focused on aseptic pharmaceutical manufacturing. In this role, you'll be responsible for ensuring that operations across commercial supply chains, including contract manufacturers and internal sites, comply with global regulatory expectations, Elanco's quality standards, and industry best practices, particularly in sterile/aseptic environments.
Your Responsibilities:
  • Conduct end-to-end audits of aseptic pharmaceutical manufacturing operations, including internal sites and external partners, to evaluate compliance with current Good Manufacturing Practices (cGMP), Elanco quality standards, and applicable global regulations
  • Develop detailed audit plans, lead pre-audit risk assessments, and produce comprehensive audit reports that highlight findings, assess risk level, and provide clear recommendations to stakeholders at all levels
  • Mentor and train new auditors, supporting their qualification process and contributing to the continuous improvement of audit processes and audit team capabilities
  • Lead risk assessments across commercial supply chains-integrating audit findings and operational risks to influence compliance strategy, quality oversight, and mitigation plans
  • Support business continuity and product supply by auditing critical aseptic suppliers, participating in mock inspections, and conducting due diligence evaluations for new partnerships and acquisitions

What You Need to Succeed (minimum qualifications):
  • Education: Bachelor's Degree (or equivalent work experience) in physical or biological sciences, engineering, or other technical area, or combination of education and experience
  • Required Experience: Minimum of 5 years of auditing experience in aseptic pharmaceutical manufacturing, with a deep understanding of sterile product processes and global compliance requirements
  • Top 2 skills: Ability to identify and communicate quality and regulatory risks with technical and strategic insight; strong interpersonal and technical writing skills

What will give you a competitive edge (preferred qualifications):
  • Demonstrated success in auditing aseptic or sterile manufacturing platforms under FDA, EMA, or similar regulatory oversight
  • Experience leading or contributing to quality improvement initiatives, such as Six Sigma or Lean projects
  • Proficiency in identifying compliance trends and translating data into risk-based quality strategies
  • Ability to build trust and influence across global cross-functional teams and third-party partners
  • Strong ability to manage conflict, drive resolution, and deliver constructive feedback professionally

Additional Information:
  • Location: Global Elanco Headquarters - Downtown Indianapolis, IN - Hybrid Work Environment
  • Travel: Up to 50% domestic and international travel annually; trips typically 1-2 weeks in duration, sometimes on short notice

Don't meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
Elanco Benefits and Perks:
We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:
  • Multiple relocation packages
  • Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
  • 8-week parental leave
  • 9 Employee Resource Groups
  • Annual bonus offering
  • Flexible work arrangements
  • Up to 6% 401K matching

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job-related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.

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