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Quality Assurance Auditor Resume Example

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QUALITY ASSURANCE AUDITOR
Professional Summary

I am a very responsible and hard working employee, following all safety rules and requirements. While always Maintaining a clean and organized work area and always go above and beyond to assure the job is done well.

Skills
  • Take lead when absence of my manager.
  • Flexible and accommodating in the QA.
  • Sign off COCS train new employees ISO certified.
  • Very Punctual.
  • Key performance indicators
  • Workplace safety
  • Production Monitoring
  • Employee Evaluation
  • Safety processes and procedures
  • Staff education and training
  • Data management
Work History
Quality Assurance Auditor05/2016 to 04/2021Company Name, City,State
  • Completed timely quality reports highlighting deficiencies and recommending corrective actions.
  • Delivered third-party audit services at client locations, keeping operations in compliance with regulatory requirements and ISO standards.
  • Compared quantity, quality and labeling of customer orders to check accuracy and completeness.
  • Determined correct procedures for inspection and review to standardized audit processes.
  • Evaluated finished products and assigned grades based on factors such as color and texture.
  • Trained and reviewed work of junior personnel on departmental responsibilities.
  • Participated in compliance inquiries and provided interpretation of data to guide investigators in creation of Corrective and Preventive Actions.
  • Maintained meticulous clinical trial documentation to show compliance with institutional policies and federal regulations.
  • Performed continuous random spot reviews of daily log pages, non-routine and work package contents for completeness, correct use of appropriate references and approved data.
  • Verified manufacturing team's compliance with quality control processes to help minimize rework and keep costs low.
  • Inspected raw and in-processed materials to determine quality and any not meeting minimum standards.
  • Helped maximize output quality by approving production tests and specifications in advance and communicating required changes to supervisors.
  • Reviewed and resolved issues raised during release of API, Safety Assessment or clinical supply lots for conformance to appropriate regulatory requirements.
  • Reviewed work instructions and production strategies to verify compliance with established standards.
  • Conducted organizational safety program reviews per department protocols.
  • Compiled clinical research data into audit reports and shared with research teams and lead investigators.
  • Audited clinical trials through review of research protocols and regulations compliance.
  • Monitored departmental forms for compliance to submissions rules and guidelines.
  • Identified issues of non-compliance and elevated reports to senior personnel.
  • Gathered and reviewed current data to determine areas in need of improvement.
  • Prepared for clinical research audits and conducted follow-up assignments reviewing documentation for Internal Review Board submissions, informed consent approvals and eligibility criteria.
  • Verified all work accomplished by external company contractors, vendors and repair facilities met and exceeded applicable quality audits.
  • Inspected work areas regularly to identify safety practices, quality control procedures and worker actions in need of improvement.
Assembly Supervisor07/2011 to 09/2015Company Name, City, State
  • Checked all production goods and reported any deficiencies.
  • Worked directly with QA personnel to identify and correct defects.
  • Planned employee rules and shift timings.
  • Supervised 20 workers and coordinated daily work activities
  • Reported machine and equipment malfunctions.
  • Prepared monthly and yearly reports for management.
  • Filed all documentation correctly and efficiently.
  • Created labels and packaging using label making software and label machines.
  • Evaluated employee skills and knowledge regularly, providing hands-on training and mentoring to individuals with lagging skills.
  • Built, supervised and mentored teams and leaders in receiving and inbound operations.
  • Collaborated with other leaders and executives to direct workflow and support operations.
  • Led warehouse improvement initiatives to advance operational efficiencies and increase revenue.
  • Maximized productivity by keeping detailed records of daily progress and identifying and rectifying areas for improvement.
Sample Quality Technician 05/2003 to 12/2008Company Name, City, State
  • Sampled materials and products to conduct in-depth measurements and tests.
  • Made recommendations on ways to improve testing procedures, production processes and training.
  • Documented and executed detailed test plans and test cases and summarized and logged audit findings for reporting purposes.
  • Determined root cause of deviations and non-conforming results and implemented appropriate corrective and preventive actions throughout product development process.
  • Evaluated results against design standards and compliance requirements.
  • Safeguard customer requirements as well as product quality standards by delivering support.
  • Developed and audited practices, programs and reporting system metrics for optimal efficiency.
  • Evaluated samples against standards by completing measurements, visual inspections and other established tests.
Education
Star Career Academy - Philadelphia, City, StateAssociate in Cardiology , Cardiology Technician , 06/2011
Varina High School, City, StateHigh School Diploma, 06/1982
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Resume Overview

School Attended

  • Star Career Academy - Philadelphia
  • Varina High School

Job Titles Held:

  • Quality Assurance Auditor
  • Assembly Supervisor
  • Sample Quality Technician

Degrees

  • Associate in Cardiology , Cardiology Technician 06/2011
    High School Diploma , 06/1982

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