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Quality assurance auditor skills for your resume and career

15 quality assurance auditor skills for your resume and career
1. Patients
- Reviewed surgical and endoscopic patients' medical charts to ensure accuracy and patient safety for a limited-term Joint Commission study.
- Reviewed the entire medical record of discharged patients within two weeks of the discharge date.
2. ISO
- Researched and documented ISO 9000 standard specifications to establish QA operational methodology for the entire Quality Assurance Team.
- Assisted in developing and conducting annual ISO training for all departments resulting in improved QMS responsibility and awareness.
3. Clinical Trials
- Established/revised and conducted internal monitoring of all aspects of the central pathology services performed and overseen by Clinical Trials.
- Identified and assessed regulation conformance risks and business practices to ensure compliance of clinical trial activities.
4. FDA
The Food and Drug Administration (FDA) is a division of the US Department of Health and Human Services that regulates the production and sale of food, pharmaceutical products, medical equipment, and other consumer goods, as well as veterinary medicine. The FDA is now in charge of overseeing the manufacture of products like vaccines, allergy treatments, and beauty products.
- Improved and monitored compliance with applicable FDA Quality System Regulations, management policies, and established procedures.
- Inspected manufactured products to ensure compliance with FDA standards and cooperatively formulated solutions to reduce errors.
5. Quality Assurance Audits
- Perform Quality Assurance audits on incoming and finished products - Monitor Quality Guidelines and report results in weekly meetings
- Performed complex operational compliance and quality assurance audits of disability benefit plans for contractual clients.
6. GMP
GMP stands for Good Manufacturing Practice. It is a system that ensures that all products like food, beverages, and medicinal drugs that are produced comply with the quality standards. It helps in minimizing the risks and hazards that cannot be eliminated after the testing of final products.
- Identified discrepancies for remediation to ensure Quality of GMP documents was in compliance with regulatory requirements, established standards and specifications.
- Team member of facility auditing processes which included record keeping practices, GMP manufacturing management and overall facility maintenance/cleanliness.
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- Communicate audit findings to various levels of management and identify opportunities to improvement in the design and effectiveness of key controls.
- Verified, documented and communicated all discrepancies, issued audit findings and evaluated the effectiveness of corrective actions.
8. Quality Standards
Quality standards are a specific level of standards of products that are set by the companies for the customers that have to be met and maintained throughout the process until the time of delivery. Quality standards are information that includes the customer's requirements, guidelines, and characteristics for the needed final product or service.
- Maintained quality standards by auditing and approving incoming materials, in-process production, and finished products; recording quality results.
- Processed new account applications and transaction processing requests from brokers and customers, while exceeding division quality standards.
9. Audit Reports
- Generated timely study audit reports forwarded to lead research technician, study director, and testing facility management.
- Analyzed audit results, prepared audit reports, and made recommendations for improvements and identified potential problems.
10. GLP
GLP stands for "good laboratory practice." This refers to the integrity and quality measures that non-clinical laboratories have in place to ensure accurate research and market testing. GLP is most often used in pharmaceutical companies where new drugs must be tested before being approved for sale, but the practice can also be used in food packaging and preparation test centers.
- Developed curriculum for training sessions including Introductory GLP Training, GLP Documentation Training, and Computer Validation Training.
- Review protocols to ensure experimental design is adequately described and all GLP requirements are met.
11. Corrective Action
- Authored and issued over 500 high-quality inspection reports and ensured corrective actions were adequate to resolve the identified technical documentation deficiencies.
- Maintained the sites manufacturing hygiene program for compliance by conducting continuous bacteria testing and provided corrective action for any bacteria findings.
12. Product Quality
Product quality is the basic element of a business. It means to add features in a product or service in such a way that it meets the needs and wants of the customers. Enhancing the product quality also means improve the goods from any existing defects to ensure customer satisfaction.
- Determine overall research product quality by conducting and evaluating various product tests and tests related to ingredients and packaging.
- Monitor and control production using all of these methodologies for improved product quality and cost effective manufacturing process.
13. Management System
A management system is a set of policies, processes, and procedures taken by an organization or a business to ensure it can fulfill its tasks and achieve its objectives. A management system makes sure that the company excels financially and improves the user experience. The management system also takes care of the worker's and employees' needs and manages their workload and oversees their performance. Apart from interior matters of the company, a management system also deals with exterior matters like legislations, tax matters, and law issues.
- Administered company PharmaReady electronic document management system.
- Maintain inspection/audit logs, files and related documentation as required by the Quality Management System and Quality System Regulations.
14. Internal Audit
Internal audit is an evaluation process that ensures that a company's risk management, governing body, and other internal processes are running effectively. People who perform internal audits must be highly qualified, have experience, and knowledge to work accordingly with the international standards and the code of ethics.
- Conduct internal auditing of Foreclosure and Bankruptcy attorney firms to ensure operational compliance with statutory guidelines and Wells Fargo internal expectations.
- Performed internal audits of manufacturing operations including aseptic filling, component and equipment preparation, and product formulation.
15. CFR
CFR, or Code of Federal Regulations, is the codification of general and permanent regulations published in the federal register by executive agencies and departments of the government of the federation. Its aim is to present the official and complete text of government regulations in one organized publication and provide a comprehensive reference for anyone who needs to know.
- Manage Change Control and Training Quality programs with emphasis on quality improvement and compliance with CFR and Consent Decree.
- Performed aircraft conformity inspections in accordance with the aircraft on certificate process (14 CFR part 135).
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List of quality assurance auditor skills to add to your resume

The most important skills for a quality assurance auditor resume and required skills for a quality assurance auditor to have include:
- Patients
- ISO
- Clinical Trials
- FDA
- Quality Assurance Audits
- GMP
- Audit Findings
- Quality Standards
- Audit Reports
- GLP
- Corrective Action
- Product Quality
- Management System
- Internal Audit
- CFR
- GCP
- PowerPoint
- Regulatory Compliance
- Excellent Interpersonal
- Audit Results
- Process Improvement
- External Audits
- CAPA
- Process Audits
- ICH
- Quality System
- Internal Controls
- Qa Management
- Vendor Audits
- Quality Issues
- CMS
- Financial Statements
- FAA
- QMS
- AQL
- Quality Checks
- Compliance Audits
- R
- Preventive Actions
- EPA
- Production Lines
- Medicaid
- Federal Regulations
- HACCP
- Study Protocols
- Customer Complaints
- Test Results
- Qa Support
- SPC
Updated January 8, 2025