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Fda Auditor Jobs in Tennessee (NOW HIRING)

The Pictsweet Company

Director, Food Safety

Bells, TN · On-site

Assure that The Pictsweet Company meets Food Safety, Quality, and Legality compliance for FDA FSMA ... Auditing. * Assure that The Pictsweet Company maintains its systems and programs in a manner to ...

The Pictsweet Company

Director, Food Safety

Bells, TN · On-site

Assure that The Pictsweet Company meets Food Safety, Quality, and Legality compliance for FDA FSMA ... Auditing. * Assure that The Pictsweet Company maintains its systems and programs in a manner to ...

Pictsweet Company

Director, Food Safety

Bells, TN · On-site

$90 - $120/hr

Assure that The Pictsweet Company meets Food Safety, Quality, and Legality compliance for FDA FSMA ... Auditing. * Assure that The Pictsweet Company maintains its systems and programs in a manner to ...

United Employment Group

Be Seen First

Quality Assurance Engineer

Memphis, TN · On-site

$90K - $110K/yr

Must have working knowledge of the FDA 21 CFR Part 820 Quality System Regulation. * Working knowledge of ISO 13485:2016 Standard is preferred. * Current certified ISO 13485:2016 Lead Auditor ...

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Fda Auditor information

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$30K

$69.2K

$110.3K

How much do fda auditor jobs pay per year?

As of Sep 1, 2026, the average yearly pay for fda auditor in Tennessee is $69,211.00, according to ZipRecruiter salary data. Most workers in this role earn between $48,600.00 and $89,400.00 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 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.

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 often required or preferred. Strong attention to detail, knowledge of FDA regulations, and auditing skills are essential for success in this role.

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 sometimes overtime pay, especially when conducting inspections or audits outside regular hours.

What are the most commonly searched types of Fda Auditor jobs in Tennessee?

The most popular types of Fda Auditor jobs in Tennessee are:

What are popular job titles related to Fda Auditor jobs in Tennessee?

For Fda Auditor jobs in Tennessee, the most frequently searched job titles are:

What job categories do people searching Fda Auditor jobs in Tennessee look for?

The top searched job categories for Fda Auditor jobs in Tennessee are:

Fda Auditor jobs near you
Infographic showing various Fda Auditor job openings in Tennessee as of August 2026, with employment types broken down into 80% Full Time, 15% Part Time, 4% Contract, and 1% Nights. Highlights an 87% Physical, 2% Hybrid, and 11% Remote job distribution, with an average salary of $69,211 per year, or $33.3 per hour.

Senior Quality Assurance Specialist - Computer Systems and Data Integrity

LabConnect

Johnson City, TN • On-site, Remote

$79K - $109K/yr

Full-time

Medical, Vision, Life, Retirement, PTO

Posted 26 days ago

Job description

Overview
LabConnect improves lives by partnering with pharmaceutical and biotech companies, and clinical research organizations (CROs) to accelerate the development of new medicines around the world.
We are an independent, global, one-stop-shop focused on delivering Central Laboratory Services that are tailor-made, timely and flexible to meet the evolving study demands of traditional to increasingly complex trials. Additionally, we provide Functional Service Provider (FSP) Solutions, supporting our clients with scientific and technical expertise, acting as an extension of their team, coordinating all laboratory related needs, advising on strategies for lab data collection and providing end-to-end analytical and logistical solutions.
The Senior Quality Assurance Specialist is responsible for ensuring that computerized systems used in GxP-regulated environments are validated and maintained in compliance with applicable regulations. This role also ensures that data integrity principles are upheld throughout the system lifecycle, supporting quality assurance and regulatory compliance.
The ideal candidate will stay current with evolving systems, data privacy regulations, security strategies, and CSV compliance procedures in a dynamic and growing organization. Success in this role depends on the ability to navigate a complex regulatory landscape, client expectations while ensuring internal alignment and accountability.
Essential Duties and Responsibilities
  • Oversee all aspects of Computer System Validation activities for both newly implemented and modified systems through the entire software life cycle, ensuring compliance with regulatory requirements (e.g., FDA 21 CFR Part 11, EU Annex 11) and internal quality standards. Collaborate cross-functionally with IT, and system owners to align validation strategies, oversee documentation, and ensure timely execution of validation deliverables throughout the system lifecycle.
  • Plan and perform audits of IT and technology vendors, Review audit findings and validation reports to assess compliance gaps and system risks. Actively participate in root cause analysis (RCA) sessions and collaborate with cross-functional SMEs to agree/approve robust and effective Corrective and Preventive Actions (CAPAs).
  • Assist with risk assessments of new and proposed technologies including contributions to Artificial Intelligent (AI) advisory team.
  • Create, Approve and ensure internal LC SOPs and processes are designed for regulatory compliance as applicable to computerized systems and data integrity, data privacy (e.g. GxP, FDA 21 CFR Part 11, and EU Annex 11).
  • Ensure proper documentation for CSV and Data Integrity projects, including risk control metrices, compliance assessments, process narratives, testing, issue evaluation, and reporting.
  • Manage and execute day-to-day compliance operational tasks, including client and vendor IT questionnaires, compliance metrics reporting, audit finding responses, internal audits, and document reviews.
  • Conduct comprehensive IT supplier qualification reviews to assess the compliance, reliability, and data integrity practices of third-party vendors.
  • Ensure life cycle management of GxP Computerized systems through QMS policies, documentation and change control.
  • Prepare KPIs in support of quality reporting to management. Assist in other QA tasks as assigned, including Veeva Vault workflows, reporting and configurations.
  • Identify opportunities for continuous quality improvement by analyzing validation processes, audit findings, and system performance metrics. Develop and implement actionable plans to enhance compliance, efficiency, and data integrity across computerized systems.
  • Keep abreast of regulatory and IT compliance developments and evolving best practices in compliance control and data integrity.

Education and Experience
  • Bachelor's degree in information technology or related field; and 6 years of relevant experience 4+ years of experience working in at least one of the following regulatory settings: FDA 21 CFR 11, Annex 11, ISO 27001, SOX, HIPAA, HITECH, CLIA, CAP, GCP .
  • Experience in clinical trials and clinical laboratory, biotech or Pharma industry with focus on computerized systems, IT processes and regulatory compliance. Specific QA roles overseeing computerized systems life cycle and DI policies and procedures. Experience with core IT applications used in a regulated environment, including Veeva, LIMS etc.
  • Recognized IT auditor, Certified Auditor accreditation or information security qualification (e.g. CISA, QICA, CISSP, CRISC, ISO27001 Lead Auditor, SSCP) preferred.

Skills and Ability
  • Ability to take the initiative, dependable, and work with little supervision while being resilient to change
  • Ability to work within a fast-paced, cross-cultural, and cross-functional team environment
  • Ability to adhere to established timelines, processes and procedures
  • Excellent attention to detail.
  • Strong planning and problem-solving skills.
  • Self-motivation and ability to work well independently as well as using a collaborative team approach.
  • Ability to adapt to changing environments and requirements.
  • Excellent organization and time management skills, communication, multitasking, interpersonal and listening skills.
  • Ability to adhere to quality and regulatory requirements while still meeting business needs.
  • Public speaking skills.
  • Business acumen.
  • To perform this job successfully, an individual must have working knowledge of Microsoft Office applications including word processing software, spreadsheet software, PowerPoint, and MS Project and database software.

Supervisory Responsibilities: None
Physical Demands:
While performing the duties of this job, the occupant is regularly required to:
  • Prolonged periods of sitting at a desk and working on a computer.
  • Prolonged use of computer and headphones for conference calls.
  • Communicate effectively via phone, video, and email.
  • Use hands and fingers to operate a computer and other office equipment.
  • Specific vision abilities required by this job include close vision, color vision, depth perception and ability to adjust focus.

Travel Requirements: Minimal
Join our team and discover how your work can impact patients' lives around the world!
Some of the Perks our LabConnectors Love:
  • Financial Security (Base Pay, 401k Match and Possible Annual Bonus Eligibility)
  • Health Benefits beginning on date of hire
  • PTO plan, plus 11 Paid Company Holidays, and 1 Day to Volunteer in your community
  • Short and Long-Term Disability, Life Insurance, and AD&D
  • We celebrate our differences, which enriches our culture!

In addition to great perks and challenging work assignments, we invest in our people with career growth opportunities, globally. We believe in a friendly and collaborative environment with open lines of communication. While living out our values of People First, Quality Focused, Customer Centered, Technology Driven, and Accountability Always.
We are proud to be an Equal Employment Opportunity Employer and value the diversity of our workforce. We do not discriminate on the basis of race, gender, age, disability, religion, sexual orientation, or any other protected characteristic. To learn more about equal employment opportunity, please view the posters here: https://www.dol.gov/agencies/whd/posters
LabConnect also prioritizes the privacy and security of your personal data. All candidate information is handled in accordance with General Data Protection Regulation (GDPR). To learn more, please review our Privacy Notice on our website, by navigating to https://www.labconnect.com/
If you need assistance to complete your job application, search for a job opening, or submit an online application at LabConnect, please email talent@labconnect.com or call +1 (423) 722-3155.

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