AIB Food Safety, GMP Compliance,and FDA Support compliance with AIB Consolidated Standards. Conduct ... Auditing & Continuous Improvement Perform ISO Internal process audits and supplier quality ...
AIB Food Safety, GMP Compliance,and FDA Support compliance with AIB Consolidated Standards. Conduct ... Auditing & Continuous Improvement Perform ISO Internal process audits and supplier quality ...
Knowledge of GCP auditing * Knowledge of FDA regulations regarding clinical research, ICH GCP, EMA, MHRA guidelines and applicable international regulations Additional Skills Requirements: * Strong ...
Knowledge of GCP auditing * Knowledge of FDA regulations regarding clinical research, ICH GCP, EMA, MHRA guidelines and applicable international regulations Additional Skills Requirements: * Strong ...
Knowledge of GCP auditing * Knowledge of FDA regulations regarding clinical research, ICH GCP, EMA, MHRA guidelines and applicable international regulations Additional Skills Requirements: * Strong ...
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Knowledge of GCP auditing * Knowledge of FDA regulations regarding clinical research, ICH GCP, EMA, MHRA guidelines and applicable international regulations Additional Skills Requirements: * Strong ...
Knowledge of GCP auditing * Knowledge of FDA regulations regarding clinical research, ICH GCP, EMA, MHRA guidelines and applicable international regulations Additional Skills Requirements: * Strong ...
Knowledge of GCP auditing * Knowledge of FDA regulations regarding clinical research, ICH GCP, EMA, MHRA guidelines and applicable international regulations Additional Skills Requirements: * Strong ...
Quality Assurance Specialist
Clayton, IN · On-site
Knowledge of FDA 21 CFR Parts 111, 210 and 211 and applicable cGMP pharmaceutical quality ... activities, auditing, and quality systems preferred. * Working knowledge of quality systems ...
Quality Assurance Specialist
Clayton, IN · On-site
Knowledge of FDA 21 CFR Parts 111, 210 and 211 and applicable cGMP pharmaceutical quality ... activities, auditing, and quality systems preferred. * Working knowledge of quality systems ...
Quality Assurance Specialist
Clayton, IN · On-site
Knowledge of FDA 21 CFR Parts 111, 210 and 211 and applicable cGMP pharmaceutical quality ... activities, auditing, and quality systems preferred. * Working knowledge of quality systems ...
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Quality Assurance Specialist
Clayton, IN · On-site
Knowledge of FDA 21 CFR Parts 111, 210 and 211 and applicable cGMP pharmaceutical quality ... activities, auditing, and quality systems preferred. * Working knowledge of quality systems ...
Quality Assurance Manager
Westfield, IN · On-site
Supports, actively engages, and may escort internal and external auditors (BSI, FDA, KGMP, etc). * Implements improvements to Quality Systems and tools by directing personnel to gather data on ...
Quality Assurance Manager
Westfield, IN · On-site
Supports, actively engages, and may escort internal and external auditors (BSI, FDA, KGMP, etc). * Implements improvements to Quality Systems and tools by directing personnel to gather data on ...
Quality Assurance Manager
Westfield, IN · On-site
Supports, actively engages, and may escort internal and external auditors (BSI, FDA, KGMP, etc). * Implements improvements to Quality Systems and tools by directing personnel to gather data on ...
Quality Assurance Manager
Westfield, IN · On-site
Supports, actively engages, and may escort internal and external auditors (BSI, FDA, KGMP, etc). * Implements improvements to Quality Systems and tools by directing personnel to gather data on ...
Supports, actively engages, and may escort internal and external auditors (BSI, FDA, KGMP, etc). * Implements improvements to Quality Systems and tools by directing personnel to gather data on ...
Supports, actively engages, and may escort internal and external auditors (BSI, FDA, KGMP, etc). * Implements improvements to Quality Systems and tools by directing personnel to gather data on ...
Compliance Manager
Brownsburg, IN · On-site
Participates in Regulatory/FDA inspections and audits by providing information or expediting/ obtaining information required by the inspectors/auditors. * Develops and manages the site data integrity ...
New
Compliance Manager
Brownsburg, IN · On-site
Participates in Regulatory/FDA inspections and audits by providing information or expediting/ obtaining information required by the inspectors/auditors. * Develops and manages the site data integrity ...
New
Support FDA and other regulatory inspections, customer audits, and site audit-readiness activities ... Auditing, and Document Management. * Experience using statistical tools, data analysis, trending ...
New
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Support FDA and other regulatory inspections, customer audits, and site audit-readiness activities ... Auditing, and Document Management. * Experience using statistical tools, data analysis, trending ...
New
... and FDA registered Distribution Center operation. Job Duties : · Monitors daily quality, and ... auditing · Creates, evaluates, and improves processes for increasing both efficiency and ...
... and FDA registered Distribution Center operation. Job Duties : · Monitors daily quality, and ... auditing · Creates, evaluates, and improves processes for increasing both efficiency and ...
Verify compliance with study protocols, Monitoring Plans, FDA regulations, ICH-GCP (Good Clinical ... and auditing. * Collaborate with key research and operational stakeholders at IU to identify ...
New
Verify compliance with study protocols, Monitoring Plans, FDA regulations, ICH-GCP (Good Clinical ... and auditing. * Collaborate with key research and operational stakeholders at IU to identify ...
New
The role is responsible for maintaining the HACCP and FDA Food Safety Plans while supporting the ... Auditing and other relevant certifications are also preferred. * Preferred Experience: Three or ...
The role is responsible for maintaining the HACCP and FDA Food Safety Plans while supporting the ... Auditing and other relevant certifications are also preferred. * Preferred Experience: Three or ...
Assistant Manager, Food Safety and Quality Assurance
Bristol, IN · On-site
$81K - $84K/yr
The role is responsible for maintaining the HACCP and FDA Food Safety Plans while supporting the ... Auditing and other relevant certifications are also preferred. * Preferred Experience: Three or ...
Assistant Manager, Food Safety and Quality Assurance
Bristol, IN · On-site
$81K - $84K/yr
The role is responsible for maintaining the HACCP and FDA Food Safety Plans while supporting the ... Auditing and other relevant certifications are also preferred. * Preferred Experience: Three or ...
Auditing & Compliance - Conduct technical audits of site calibration programs to ensure alignment with Elanco global standards, USDA, ISO, FDA, and GMP requirements. Ensure robust NIST traceability ...
Auditing & Compliance - Conduct technical audits of site calibration programs to ensure alignment with Elanco global standards, USDA, ISO, FDA, and GMP requirements. Ensure robust NIST traceability ...
Auditing & Compliance- Conduct technical audits of site calibration programs to ensure alignment with Elanco global standards,USDA, ISO, FDA, and GMP requirements. Ensure robust NIST traceability and ...
Auditing & Compliance- Conduct technical audits of site calibration programs to ensure alignment with Elanco global standards,USDA, ISO, FDA, and GMP requirements. Ensure robust NIST traceability and ...
Corporate Quality Senior Analyst
Greenwood, IN · Hybrid
$89K - $106K/yr
Participates as a lead auditor in the food safety and quality auditing program * Interprets quality ... Familiar with FSMA, FDA 21 CFR relating to Food Safety, Bottled Waters and Food Safety ...
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Corporate Quality Senior Analyst
Greenwood, IN · Hybrid
$89K - $106K/yr
Participates as a lead auditor in the food safety and quality auditing program * Interprets quality ... Familiar with FSMA, FDA 21 CFR relating to Food Safety, Bottled Waters and Food Safety ...
Corporate Quality Senior Analyst
Greenwood, IN · On-site
$89K - $106K/yr
Participates as a lead auditor in the food safety and quality auditing program * Interprets quality ... Familiar with FSMA, FDA 21 CFR relating to Food Safety, Bottled Waters and Food Safety ...
Corporate Quality Senior Analyst
Greenwood, IN · On-site
$89K - $106K/yr
Participates as a lead auditor in the food safety and quality auditing program * Interprets quality ... Familiar with FSMA, FDA 21 CFR relating to Food Safety, Bottled Waters and Food Safety ...
Verifiable aptitude of FDA regulations. * ASQ and/or ISO Auditor Certifications preferred. * Intermediate public speaking and presentation skills. * Ability to track and present quality metrics ...
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Verifiable aptitude of FDA regulations. * ASQ and/or ISO Auditor Certifications preferred. * Intermediate public speaking and presentation skills. * Ability to track and present quality metrics ...
Fda Auditor information
See Indiana salary details
$31.4K - $39.1K
2% of jobs
$39.1K - $46.7K
17% of jobs
$50.7K is the 25th percentile. Wages below this are outliers.
$46.7K - $54.4K
12% of jobs
$54.4K - $62K
11% of jobs
The median wage is $66.1K / yr.
$62K - $69.7K
17% of jobs
$69.7K - $77.3K
7% of jobs
$77.3K - $85K
6% of jobs
$85K - $92.6K
3% of jobs
$92.8K is the 75th percentile. Wages above this are outliers.
$92.6K - $100.3K
17% of jobs
$100.3K - $108K
4% of jobs
$108K - $115.6K
4% of jobs
$31.4K
$72.6K
$115.6K
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 do FDA auditors make?
How to become an FDA auditor?
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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Job description
The Quality and Training Specialist supports the organization'sQuality Management System (QMS) to ensure compliance with ISO standards,applicable AIB (American Institute of Baking) food safety and GoodManufacturing Practice (GMP) requirements, as well as FDA regulations, thisincludes all related QMS established audits that need completed, weekly,monthly, etc. This role also supportsthe training and development of Coowners by providing training to Co-owners,coordinating, tracking, and recording the completion of warehouse job skillsetson provided tracking spreadsheets or training database, skill competencymatrix, etc. Responsibilities includedeveloping and delivering presentations and training sessions for operations Coownerson topics such as QMS principles, ISO standards, compliance requirements, andvarious training programs.
Responsibilities
Quality Management System
Maintain and support the company's ISO certifications, Quality Management System and Training initiatives.
Control and update quality and training documentation including SOPs, work instructions, forms, and records.
Coordinate/conduct ISO internal audits and support external/3rd Party certification audits.
Track corrective and preventive actions (CAPA) and verify effectiveness as required.
Assist with risk assessments and process improvement initiatives.
AIB Food Safety, GMP Compliance,and FDA
Support compliance with AIB Consolidated Standards.
Conduct facility inspections and GMP audits.
Assist with food safety documentation and recordkeeping.
Participate / conduct food safety training and awareness programs.
Support root cause investigations related to quality or food safety issues.
Auditing & Continuous Improvement
Perform ISO Internal process audits and supplier quality evaluations.
Analyze quality trends and recommend corrective actions.
Support continuous improvement initiatives.
Assist with customer complaints (CAPA's) and nonconformance investigations as required.
Training &Communication
Provide training to both Leadership / Co-owners on quality processes, ISO standards, and GMP requirements, Food Safety, and various operations job skills, WMS system training, etc.
Audit training progress across the network ensuring compliance.
Promote a culture of quality and continuous improvement throughout the network.
Communicate audit findings and corrective actions across departments.
Provide follow-up on actions taken and keep the Operations network informed.
ADDITIONAL DUTIES
Take on assignments and work projects
Work independently
Ability to prioritize work assignments to meet assigned deadlines
About DH
Sourced by ZipRecruiter
Industry
Traveler accommodation
Company size
51 - 200 Employees
Headquarters location
Manassas, VA, US
Year founded
2005