... 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 ...
... 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
Quality Assurance Supervisor
Colorado Springs, CO · On-site
$60K - $80K/yr
... 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 ...
Quick apply
Be Seen First
Quality Assurance Supervisor
Colorado Springs, CO · On-site
$60K - $80K/yr
... 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
Quality Assurance Supervisor
Colorado Springs, CO · On-site
$60K - $80K/yr
... 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 ...
Quick apply
Be Seen First
Quality Assurance Supervisor
Colorado Springs, CO · On-site
$60K - $80K/yr
... 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
$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 ...
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 ...
... FDA 21 CFR 820) Preferred: · ASQ certified Quality Manager, ISO Lead Auditor Certification, Technical Writing · Understanding and familiarity with design history files, change management ...
... FDA 21 CFR 820) Preferred: · ASQ certified Quality Manager, ISO Lead Auditor Certification, Technical Writing · Understanding and familiarity with design history files, change management ...
Quality Assurance Supervisor
Colorado Springs, CO · On-site
$60K - $70K/yr
... 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 ...
Quality Assurance Supervisor
Colorado Springs, CO · On-site
$60K - $70K/yr
... 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 ...
... and auditing Design History Files (DHF). • Remediating design output documentation to meet ... FDA, ISO, and European Medical Device standards. • Developing and maintaining standards for ...
... and auditing Design History Files (DHF). • Remediating design output documentation to meet ... FDA, ISO, and European Medical Device standards. • Developing and maintaining standards for ...
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 ...
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 ...
... 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 ...
... 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 ...
... 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 ...
Sample Login Technician
$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 ...
Sample Login Technician
$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 ...
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 ...
Demonstrated familiarity with/experience of with internal or external auditing * Experience in ... FDA), CC (MHRA; FDA) * Previous experience in GMP production sites * Understanding regulatory ...
Demonstrated familiarity with/experience of with internal or external auditing * Experience in ... FDA), CC (MHRA; FDA) * Previous experience in GMP production sites * Understanding regulatory ...
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 ...
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 ...
Sample Login Technician
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 ...
Sample Login Technician
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 ...
... auditing requirements have been completed prior to the start of a study. * Will produce, as ... Working knowledge of FDA, NIH, and OHRP regulatory requirements and ICH GCP guidelines. * Excellent ...
... auditing requirements have been completed prior to the start of a study. * Will produce, as ... Working knowledge of FDA, NIH, and OHRP regulatory requirements and ICH GCP guidelines. * Excellent ...
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 ...
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 ...
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 ...
Fda Auditor information
See Colorado salary details
$34.7K - $43.2K
2% of jobs
$43.2K - $51.6K
17% of jobs
$56K is the 25th percentile. Wages below this are outliers.
$51.6K - $60.1K
12% of jobs
$60.1K - $68.5K
11% of jobs
The median wage is $73K / yr.
$68.5K - $77K
17% of jobs
$77K - $85.5K
7% of jobs
$85.5K - $93.9K
6% of jobs
$93.9K - $102.4K
3% of jobs
$102.5K is the 75th percentile. Wages above this are outliers.
$102.4K - $110.8K
17% of jobs
$110.8K - $119.3K
4% of jobs
$119.3K - $127.8K
4% of jobs
$34.7K
$80.2K
$127.8K
How much do fda auditor jobs pay per year?
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?
What do FDA auditors make?
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:
What job categories do people searching Fda Auditor jobs in Colorado look for?
The top searched job categories for Fda Auditor jobs in Colorado are:

Quality Assurance Supervisor
Colorado Springs, CO
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!Â
Position Summary:Â
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.Â
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.Â
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.Â
Essential Functions and Basic Duties:
QA Leadership & Daily Oversight:
- Supervise day-to-day QA activities across manufacturing, packaging, and quarantine operationsÂ
- Lead, train, and mentor QA Technicians, providing coaching, performance feedback, and scheduling supportÂ
- Serve as a visible quality presence on the production floorÂ
- Exercise authority—with organizational support—to stop production or withhold product release when quality or compliance risks are identifiedÂ
Quality Systems & Compliance:
- Support equipment qualifications (IQ/OQ) and cleaning validation activitiesÂ
- Partner with Supplier Quality to support raw-material and vendor qualification processesÂ
- Review batch records and oversee documentation accuracy and completenessÂ
- Coordinate deviation investigations, nonconformance documentation, and CAPA activitiesÂ
- Support root-cause analysis and track CAPA effectivenessÂ
- Manage change-control documentation to ensure traceability and regulatory alignmentÂ
- Track and trend quality metrics and report findings to Quality leadershipÂ
Training & Technical Support:
- Coordinate QA-related training programs in collaboration with HR and department leadersÂ
- Ensure training records are current and aligned with role-specific competenciesÂ
- Act as a technical resource and mentor for QA TechniciansÂ
Auditing & Inspection Readiness:
- Participate in internal and external audits, serving as a subject matter expertÂ
- Support preparation for FDA and customer inspectionsÂ
- Monitor and follow up on corrective actions resulting from audit findingsÂ
Cross-Functional Collaboration & Continuous Improvement:
- Partner with Manufacturing, Product Development, and Supply Chain to support compliant, efficient operationsÂ
- Participate in quality review boards and continuous improvement initiativesÂ
- Identify opportunities to improve documentation flow, approval timelines, and QA processesÂ
- Support enhancements to electronic Quality Management Systems (QMS)Â
Performance Measurements:
- Accuracy and timeliness of batch record and document reviewsÂ
- Deviation and CAPA closure effectivenessÂ
- Audit readiness and inspection outcomesÂ
- Training completion and team development progressÂ
- Contributions to quality culture and process improvement initiativesÂ
QualificationsÂ
Education / Certifications:Â
- Bachelor’s degree in a scientific or technical discipline (Biology, Chemistry, Food Science, or similar) preferredÂ
- Equivalent regulated-industry experience will be consideredÂ
Required Knowledge:
- Strong working knowledge of cGMPs, FDA regulations, and Good Documentation Practices (GDP)Â
- Experience working with ERP systems and electronic QMS platformsÂ
Required Experience:
- 4–6 years of Quality Assurance experience in a regulated manufacturing environment (dietary supplements, nutraceuticals, pharmaceuticals, food, or similar FDA-regulated industry)Â
- 1–2 years of experience in a lead or supervisory capacity preferredÂ
- Hands-on experience with batch record review, deviation investigations, CAPA management, and internal auditsÂ
Skills / Abilities:
- Strong analytical, organizational, and technical writing skillsÂ
- Ability to lead, mentor, and influence others in a fast-paced manufacturing environmentÂ
- Detail-oriented, accountable, and comfortable making quality-driven decisions
Work Environment & Physical RequirementsÂ
- Primarily office-based with regular time spent in manufacturing areasÂ
- Requires extended periods of computer work and walking the production floorÂ
- Occasional lifting up to 20 lbsÂ
- Use of PPE including lab coat, hairnet, safety glasses, and hearing protection as requiredÂ
Career GrowthÂ
NGW is committed to developing Quality leaders. This role offers a defined progression path:Â
Director of QualityÂ
Quality Manager Â
Quality Assurance SupervisorÂ
Advancement is supported through leadership exposure, system ownership, and cross-functional collaboration.
About New Generation Wellness
Sourced by ZipRecruiter
Company size
51 - 200 Employees
Headquarters location
Colorado Springs, CO, US