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Quality associate skills for your resume and career
15 quality associate skills for your resume and career
1. Patients
- Investigated complaints by analyzing initial information and following up with patients by phone.
- Reviewed and processed medical device complaints for renal dialysis patients.
2. 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.
- Participated in Operations and QA departmental meetings for review of quality concerns and help identify areas for process improvement.
- Conduct hold investigations to resolve deviations related to raw materials and finished products and provide QA disposition recommendations.
3. 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.
- Reviewed training requirements on FDA Quality System and Medical Device Reporting Regulations periodically to maintain process knowledge and personal development plan.
- Performed audits of manufacturing areas to identify and correct compliance gaps and quality system concerns.
4. Quality Specifications
- Maintained the quality specifications as provided by Engineering.
- Initiate investigations and report any supplies that have not met quality specifications and requirements prior to use.
5. 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.
- Prepare process validation report and annual product quality review reports.
- Conducted preventative action surveillance for production and product quality.
6. Customer Service
Customer service is the process of offering assistance to all the current and potential customers -- answering questions, fixing problems, and providing excellent service. The main goal of customer service is to build a strong relationship with the customers so that they keep coming back for more business.
- Managed renal peritoneal dialysis customer complaints utilizing GDP and customer service.
- Resolved customer issues by providing customer service.
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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.
- Work cross functionally to identify pinch points in overlapping processes and drive continuous improvement through successful project management skills.
- Participate in continuous improvement efforts and projects by developing plans to investigate identified risks of medical products.
8. Customer Complaints
- Communicated with Clinical Trial Manager and International Senior Management to address customer complaints and Deviations from Clinical Research Units.
- Respond to customer complaints and support the investigation process for complaints associated with distributed finished product.
9. 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.
- Coordinated between Quality Assurance and Quality Control departments for preparing responses to FDA inquiries and deficiencies during regulatory submissions and inspections.
- Participated in Start-up and initial Validation of site including FDA Inspection resulting in approval of the Manufacturing Facility.
10. Data Analysis
- Create standardized processes, and data analysis to help automotive component manufacturers achieve greater efficiency and higher component quality.
- Mastered applicable computer applications related to word processing, reporting, data analysis and complaint management.
11. Cgmp Regulations
- Assist the Center Quality Manager to ensure that cGMP regulations are followed.
- Will ensure greater partner satisfaction and tighter adherence to cGMP regulations.
12. Data Entry
Data entry means entering data into a company's system with the help of a keyboard. A person responsible for entering data may also be asked to verify the authenticity of the data being entered. A person doing data entry must pay great attention to tiny details.
- Led development and vendor management for custom web-based learning platform that supported data entry and management of clinical data.
- Master Data entry and verification.
13. Process Improvement
- Identify areas for process improvement; participate in process improvement; and monitor change for effectiveness through a problem management process.
- Assisted Distribution in managing Distribution projects, investigations and process improvements in an efficient, accurate and timely manner.
14. DMS
- Gained proficiency in SAP DMS system as initiator and document coordinator, facilitated departmental document changes.
- Performed compliance review of controlled documents and executed audits of DMS document subsets.
15. ISO
- Participated in regulatory inspections; maintained a working knowledge of regulatory requirements according to ISO 19001.
- Supervised audits on various business units and assisted in maintaining the ISO Certified Quality Management System.
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List of quality associate skills to add to your resume
The most important skills for a quality associate resume and required skills for a quality associate to have include:
- Patients
- QA
- Quality System
- Quality Specifications
- Product Quality
- Customer Service
- Continuous Improvement
- Customer Complaints
- FDA
- Data Analysis
- Cgmp Regulations
- Data Entry
- Process Improvement
- DMS
- ISO
- Internal Audit
- Medical Devices
- CAPA
- Corrective Action
- Quality Standards
- SPC
- Sample Shipment
- Regulatory Compliance
- Product Releases
- Management System
- PowerPoint
- GDP
- Preventive Actions
- Quality Issues
- CFR
- R
- Work Ethic
- SME
- External Audits
- Sigma
- Supplier Quality
- Environmental Monitoring
- QMS
- TrackWise
- Quality Checks
- GLP
- Test Methods
- Lims
- Kaizen
- USP
- Unsuitable Test Results
- SQL
- Customer Specifications
- OOs
- EMA
Updated January 8, 2025
