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Quality assurance specialist skills for your resume and career

15 quality assurance specialist skills for your resume and career
1. 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.
- Perform Audits during the manufacturing process for adherence to current GMP, Specifications and ensure compliance with established regulatory requirements.
- Trained, mentored, educated and supervised line supervisors and technical staff in appropriately documenting GMP.
2. Patients
- Collected patients demographic and verified their medical insurance benefits, obtained prior-authorization as needed for DME supplies.
- Collaborated with members of the multidisciplinary team in reviewing medical records for in-house patients.
3. 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.
- Maximized profitability and eliminated liability by establishing procedures and standards that were compliant with internal, third party and FDA standards.
- Provided guidance on FDA expectations/regulations and final approval of all GAMP validation life cycle documentation within the Quality Control unit.
4. CAPA
- Provide timely data trending and metrics analysis for presentation at Monthly Metrics Review meeting for quality assessment and CAPA recommendations.
- Reduced the company's consumer complaint by monitoring CAPA efficiency and implementation of continuous Quality improvement to the production process.
5. Corrective Action
- Review and approve contractor Corrective Action Plans resulting from audit findings and perform follow-up assessments for verification and validation ensuring implementation.
- Performed site internal quality audits, developed audit agendas, generated and disseminated observation reports to include corrective action follow-up.
6. 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.
- Participated in 21 CFR electronic signature compliance and software validation completion for ARC computer system national consistency program.
- Audited laboratory and manufacturing facilities and systems to ensure compliance to CFR regulations and Consent Decree commitments.
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Continuous improvement is an ongoing process of improvement of products, services, and processes with the help of innovative ideas. It is an organized approach that helps an organization to find its weaknesses and improve them.
- Developed and implemented validation organization and continuous improvement initiatives.
- Team leader for Corporate Continuous Improvement initiative working with individuals from multiple departments to create visual aids communicating company's goals.
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.
- Introduced and implemented a program that documented and monitored monthly assay reports of vendor components to verify alignment with quality standards.
- Monitor and score calls between contact center personnel and customers/service providers in order to evaluate customer service and ensure quality standards.
9. ISO
- Conduct ISO 9001:2008 audits and review written quality procedures and documentation for adequacy and evaluate implementation and effectiveness of quality systems.
- Performed internal audits on all levels of manufacturing personnel, operational and inspection procedures in accordance to ISO requirements.
10. 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.
- Review and approve Environmental Monitoring System/Building Management System/Utilities Monitoring System/Quality.
- Lead Quality Auditor for Quality Management System, with proven history of setting and achieving quality objectives and continuously driving improvement.
11. QC
Quality control is a set of instructions or procedures to ensure a manufactured product or a service is up to the highest quality standards. This set of quality control criteria are either defined by the clients or the company itself.
- Reviewed and approved method validation protocols and reports from QC departments and contract laboratories, including specifications and deviations.
- Support Manufacturing, Packaging, QC, Material Management & Facility Department; Incoming Materials Inspection-Manufacturing Supplies.
12. PowerPoint
- Developed and delivered quality training curriculum via PowerPoint presentations for various departments including Supply Chain, Logistics, Production and Engineering.
- Tested Web-based software written in VB that interacted with Microsoft PowerPoint software created by evolving e-commerce business.
13. Quality System
A quality system is an organizational structure that helps management, procedures, and processes. The quality system helps the company to achieve its goals by following the right procedures. The quality system is usually documented and is based around a manual that defines and controls the system.
- Assisted with Quality Systems and implemented the Customer Comment Program and performed other tasks assigned directly by Quality Director.
- Assist and coordinate Management Reviews to ensure that quality systems satisfy the requirements and established quality policies and objectives.
14. Excellent Organizational
- Adhere to all confidentiality rules pertaining to job position; excellent organizational skills and customer service skills.
- Worked independently utilizing excellent organizational skills, and critical thinking.
15. Process Improvement
- Identified and recommended Process Improvements to maximize efficiency, developed and implemented plans to ensure resources are allocated for achieving objectives.
- Provided expertise on Personal Lines process improvement methodology and consults with Personal Lines Operations Management regarding process improvement opportunities and options.
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List of quality assurance specialist skills to add to your resume

The most important skills for a quality assurance specialist resume and required skills for a quality assurance specialist to have include:
- GMP
- Patients
- FDA
- CAPA
- Corrective Action
- CFR
- Continuous Improvement
- Quality Standards
- ISO
- Management System
- QC
- PowerPoint
- Quality System
- Excellent Organizational
- Process Improvement
- Internal Audit
- Product Quality
- Data Entry
- Quality Issues
- Test Results
- Quality Assurance Program
- Quality Audits
- Excellent Interpersonal
- Test Cases
- Data Analysis
- Test Scripts
- Preventive Actions
- SharePoint
- Customer Complaints
- Qa Management
- Regression
- Regulatory Compliance
- Sigma
- API
- Audit Findings
- Jira
- Qa Support
- External Audits
- Windows
- TrackWise
- Training Materials
- Federal Regulations
- GLP
- R
- Lims
- Training Programs
- Environmental Monitoring
- HIPAA
- Technical Assistance
- Product Releases
Updated January 8, 2025