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Fda Auditor Jobs in Colorado (NOW HIRING)

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... Auditing & Inspection Readiness * Participate in internal and external audits, serving as a subject matter expert * Support preparation for FDA and customer inspections * Monitor and follow up on ...

Be Seen First

... Auditing & Inspection Readiness * Participate in internal and external audits, serving as a subject matter expert * Support preparation for FDA and customer inspections * Monitor and follow up on ...

Courier

Greeley, CO · On-site

$15.25 - $19.25/hr

EAS Consulting Group - A regulatory consulting firm offering expert guidance, training, and auditing support across FDA, USDA, and other regulated sectors, powered by a large network of independent ...

Courier

Greeley, CO · On-site

$19.50/hr

EAS Consulting Group - A regulatory consulting firm offering expert guidance, training, and auditing support across FDA, USDA, and other regulated sectors, powered by a large network of independent ...

QMS Manager

Boulder, CO · On-site

$115K - $135K/yr

Strong knowledge of quality standards and regulations (ISO 9001, ISO 13485, ISO 14971, IATF 16949, FDA 21 CFR 820) Preferred * ASQ certified Quality Manager, ISO Lead Auditor Certification, Technical ...

... FDA 21 CFR 820, ISO 13485). * Partner with customers to complete qualification activities for ... Act as subject matter expert in internal auditing, CAPA, and change management activities; conduct ...

EAS Consulting Group - A regulatory consulting firm offering expert guidance, training, and auditing support across FDA, USDA, and other regulated sectors, powered by a large network of independent ...

Assistant General Manager

Denver, CO · On-site

$140K - $150K/yr

FDA, HACCP and security * Advanced Microsoft office tool skills (excel, word) * Knowledge of quality auditing, inspection methods * Detail oriented and excellent project management skills * Strong ...

Assistant General Manager

Denver, CO · On-site

$140K - $150K/yr

FDA, HACCP and security * Advanced Microsoft office tool skills (excel, word) * Knowledge of quality auditing, inspection methods * Detail oriented and excellent project management skills * Strong ...

Assistant General Manager

Denver, CO · On-site

$140 - $150/hr

FDA, HACCP and security * Advanced Microsoft office tool skills (excel, word) * Knowledge of quality auditing, inspection methods * Detail oriented and excellent project management skills * Strong ...

EAS Consulting Group - A regulatory consulting firm offering expert guidance, training, and auditing support across FDA, USDA, and other regulated sectors, powered by a large network of independent ...

Quality Control Supervisor

Denver, CO · On-site

$57K - $60K/yr

... FDA, USDA, Etc.) Manage and maintain the Company's quality inspection and product release programs ... Auditing Strong computer skills required; with knowledge in MS Office, Excel and GOLD system ...

Knowledge of quality systems and standards relevant to Medical, Energy, and Automotive industries (e.g., ISO, IATF, FDA, etc.). Preferred Certifications: * ASQ * Lead Auditor Functional/Technical ...

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Fda Auditor information

See Colorado salary details

$34.7K

$80.2K

$127.8K

How much do fda auditor jobs pay per year?

As of Aug 28, 2026, the average yearly pay for fda auditor in Colorado is $80,184.00, according to ZipRecruiter salary data. Most workers in this role earn between $56,300.00 and $103,600.00 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 Colorado?

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

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

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

Infographic showing various Fda Auditor job openings in Colorado as of August 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution, with an average salary of $80,184 per year, or $38.5 per hour.

Quality Assurance Supervisor

Colorado Springs, CO

NEW GENERATION WELLNESS
51 - 200 employees

Full-time

Re-posted 13 days ago


Job description

Quality Assurance Supervisor

As we prepare to embark on our centennial journey, New Generation Wellness (NGW) is not just marking a milestone; we are celebrating a century of commitment to health, vitality, and positive transformation. For 100 years, we've been at the forefront of wellness, pioneering innovation and shaping the future of holistic health. We invite you to be part of our legacy. Joining New Generation Wellness means becoming a part of a dynamic and successful team that values innovation, collaboration, and exceeding the needs of our customers. Here's to the next 100 years of New Generation Wellness! More importantly, here is to your success! 


Position Summary: 

The Quality Assurance Supervisor provides daily leadership and oversight of Quality Assurance activities supporting manufacturing, packaging, and quarantine operations in a cGMP-regulated environment. This role ensures compliance with FDA regulations, internal SOPs, and quality-system requirements while fostering a proactive, collaborative quality culture. 

Reporting to the Quality Manager, the QA Supervisor leads and mentors QA staff, supports audit readiness, drives documentation accuracy, and partners closely with Operations and Product Development to ensure product quality and regulatory compliance. 

This is an ideal opportunity for a hands-on QA professional ready to expand their leadership impact while maintaining direct involvement in quality systems and floor-level execution. 


Essential Functions and Basic Duties:

QA Leadership & Daily Oversight:

  • Supervise day-to-day QA activities across manufacturing, packaging, and quarantine operations 
  • Lead, train, and mentor QA Technicians, providing coaching, performance feedback, and scheduling support 
  • Serve as a visible quality presence on the production floor 
  • Exercise authority—with organizational support—to stop production or withhold product release when quality or compliance risks are identified 

Quality Systems & Compliance:

  • Support equipment qualifications (IQ/OQ) and cleaning validation activities 
  • Partner with Supplier Quality to support raw-material and vendor qualification processes 
  • Review batch records and oversee documentation accuracy and completeness 
  • Coordinate deviation investigations, nonconformance documentation, and CAPA activities 
  • Support root-cause analysis and track CAPA effectiveness 
  • Manage change-control documentation to ensure traceability and regulatory alignment 
  • Track and trend quality metrics and report findings to Quality leadership 

Training & Technical Support:

  • Coordinate QA-related training programs in collaboration with HR and department leaders 
  • Ensure training records are current and aligned with role-specific competencies 
  • Act as a technical resource and mentor for QA Technicians 

Auditing & Inspection Readiness:

  • Participate in internal and external audits, serving as a subject matter expert 
  • Support preparation for FDA and customer inspections 
  • Monitor and follow up on corrective actions resulting from audit findings 

Cross-Functional Collaboration & Continuous Improvement:

  • Partner with Manufacturing, Product Development, and Supply Chain to support compliant, efficient operations 
  • Participate in quality review boards and continuous improvement initiatives 
  • Identify opportunities to improve documentation flow, approval timelines, and QA processes 
  • Support enhancements to electronic Quality Management Systems (QMS) 

Performance Measurements:

  • Accuracy and timeliness of batch record and document reviews 
  • Deviation and CAPA closure effectiveness 
  • Audit readiness and inspection outcomes 
  • Training completion and team development progress 
  • Contributions to quality culture and process improvement initiatives 

Qualifications 

Education / Certifications: 

  • Bachelor’s degree in a scientific or technical discipline (Biology, Chemistry, Food Science, or similar) preferred 
  • Equivalent regulated-industry experience will be considered 

Required Knowledge:

  • Strong working knowledge of cGMPs, FDA regulations, and Good Documentation Practices (GDP) 
  • Experience working with ERP systems and electronic QMS platforms 

Required Experience:

  • 4–6 years of Quality Assurance experience in a regulated manufacturing environment (dietary supplements, nutraceuticals, pharmaceuticals, food, or similar FDA-regulated industry) 
  • 1–2 years of experience in a lead or supervisory capacity preferred 
  • Hands-on experience with batch record review, deviation investigations, CAPA management, and internal audits 

Skills / Abilities:

  • Strong analytical, organizational, and technical writing skills 
  • Ability to lead, mentor, and influence others in a fast-paced manufacturing environment 
  • Detail-oriented, accountable, and comfortable making quality-driven decisions

Work Environment & Physical Requirements 

  • Primarily office-based with regular time spent in manufacturing areas 
  • Requires extended periods of computer work and walking the production floor 
  • Occasional lifting up to 20 lbs 
  • Use of PPE including lab coat, hairnet, safety glasses, and hearing protection as required 

Career Growth 

NGW is committed to developing Quality leaders. This role offers a defined progression path: 

Director of Quality 

Quality Manager  

Quality Assurance Supervisor 

Advancement is supported through leadership exposure, system ownership, and cross-functional collaboration.