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Quality systems analyst skills for your resume and career
15 quality systems analyst skills for your resume and career
1. 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.
- Prepared, presented and facilitated Management Review summaries and status of the quality system to Senior Management and Company.
- Provided audit and corrective action information to the Quality System Manager for quality system metrics reporting.
2. CAPA
- Audited/evaluated line product/process and reported non-conformance and possible CAPA's.
- Subject Matter Expert and Team Leader for Management Controls, CAPA Systems, Team Member for Risk Management Team.
3. 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.
- Created/developed and facilitated training for facilitators, production personnel and management team in support of Quality Management System and SPC implementation.
- Developed strategic improvements in SOP management, electronic laboratory notebooks, data management systems, and other software applications.
4. Continuous Improvement
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.
- Report Analysis: Developed several macros to improve efficiency of report generation and rapid problem solving to support continuous improvement.
- Prepared Quality Review Board monthly presentation summarizing quality metrics and trend identification /measurement and identifies areas for continuous improvement.
5. Project Management
- Reported Daily status and communicated impediments to lead and project management.
- Assist project management and team leads with structure of the project's Process Asset Library (PAL) SharePoint.
6. 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.
- Enforced policies and procedures that would ensure that the system would withstand the scrutiny of an FDA or an ISO audit.
- Conduct internal audits as a team member or lead auditor and participate in external audits including FDA and International Body audits.
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- Project resulted in a departmental process improvement from an average of 38% to over 78% compliant in 4 months.
- Created a batch record review performance tracker as the result of a LEAN process improvement project that improved right-the-first-time batch records.
8. 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.
- Conduct evaluations and audits of production personnel to ensure procedures are being followed in accordance with GMP compliance.
- Performed Quality Assurance roles globally to assure compliance with GMP and associated countries' regulations.
9. Data Analysis
- Conducted in-depth data analysis, generating reports and presenting results to senior management.
- Perform data analysis activities and explain perceived and actual gaps to business, accounting, and technical stakeholders.
10. QMS
- Assisted process owners in creating and revising procedures in the QMS, including forms, reports and standard work.
- Serve as the Instructor for all QMS associates by providing federal and international regulations training classes.
11. ISO
- Simplified procedures by creating user-friendly documents while maintaining ISO standard requirements.
- Conducted internal process audits, including ISO, Export Control, Environmental Protection Agency (EPA), and Safety audits.
12. QA
QA, or Quality Assurance is a procedure that entails all of the steps taken to avoid any errors in the manufacturing process or in the production of the goods that a company produces. It can also include ensuring the consistency of the services rendered. Quality assurance ensures that the quality of the service delivered to consumers meets or exceeds the promised expectations. This greatly aids in the prevention of any complications that might arise after the goods or services have been distributed. It makes sure that customers are satisfied.
- Streamlined development and QA process established and managed test automation infrastructure that allowed development and QA to work more efficiently.
- Worked with the QA Department to evaluate quality control testing and quality assurance requirements on all analyses performed in laboratory.
13. Sigma
In Greek alphabets, sigma is the 18th letter that means "to sum up". In statistics, the lower case symbol of sigma is the unit of measurement for standard deviation which is used to assess the variability in a given set of data. While the upper case symbol is for summation notation means to add up all the given numbers in the data set.
- Team leader for the Six Sigma methodology.
14. External Audits
- Evaluated and monitored supplier performance and customer satisfaction by participating in management reviews and leading internal and external audits.
- Planned and conducted internal audits and facilitated external audits with regulatory and accrediting agencies.
15. Corrective Action
- Reviewed/approved root cause/corrective action/effectiveness verification.
- Performed first article inspections, prototype testing, final product testing and failure analysis, initiating universal corrective actions.
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Michael McLaughlin
Faculty, Brigham Young University - Idaho
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Michael McLaughlin
Faculty, Brigham Young University - Idaho
What hard/technical skills are most important for quality systems analysts?
Michael McLaughlin
Faculty, Brigham Young University - Idaho
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List of quality systems analyst skills to add to your resume

The most important skills for a quality systems analyst resume and required skills for a quality systems analyst to have include:
- Quality System
- CAPA
- Management System
- Continuous Improvement
- Project Management
- FDA
- Process Improvement
- GMP
- Data Analysis
- QMS
- ISO
- QA
- Sigma
- External Audits
- Corrective Action
- SharePoint
- Test Scripts
- Quality Metrics
- User Acceptance
- SME
- Lean Six Sigma
- Regression
- Test Cases
- SDLC
- Development Life
- Test Data
- Internal Audit
- SQL Server
- Test Results
- Technical Support
- TrackWise
- Training Materials
- Jira
- PPAP
- SPC
- UAT
- Oracle Sql
- CMS
- HTML
- Lean Manufacturing
- Customer Complaints
- QC
- HP ALM
- Test Scenarios
- Functional Specifications
- Test Strategy
- ETL
- Environmental Monitoring
Updated January 8, 2025