Results-driven quality assurance professional with a strong background in ensuring compliance with stringent quality standards. Skilled in conducting root cause analysis and implementing process improvements to consistently enhance product quality and operational efficiency. Demonstrated success in achieving significant improvements in product quality, defect reduction, and overall customer satisfaction.
Overview
6
6
years of professional experience
Work History
Quality Assurance Operations
JVT Advisors
10.2024 - 04.2025
Perform issuance verification of production documents and labels to meet production schedule
Maintain a strong working knowledge of the Quality Management System (QMS) and relevant GxP regulations
Performed room release to ensure that the cleanroom environments meet the required quality and safety standards before production or further processes began
Provide on the floor QA oversight and support in the GMP cleanroom to ensure compliance to GMP regulations throughout the manufacturing areas
Reviewed and approved equipment calibration and maintenance records within blue Mountain to support equipment’s/utilities
Conduct thorough reviews of batch records, ensuring adherence to established procedures, specifications and regulatory requirements
Performed in-process quality checks to maintain conformance to company’s SOP and industry regulations
Performed aseptic gowning to enter and work in cleanroom environments, ensuring compliance with GMP and FDA regulations
Assisted in airborne particle testing, surface sampling and microbial testing to assess environment quality
Perform visual inspection of final products
Identify compliance risks and escalate the issues to the appropriate levels of management for resolution
Performed raw material inspections to ensure compliance with specifications and regulatory requirements
Verify that validated processes are consistently followed on the manufacturing floor
Performed receipt and disposition of incoming patient apheresis material
Reviewed and audited logbooks to ensure accuracy, completeness, and compliance with GMP and company’s SOPs
Quality Assurance
Trelleborg Medical Solutions
11.2022 - 10.2024
Conducting thorough quality inspections, enhancing product reliability and customer satisfaction
Worked in laboratory and clean room environments when performing quality inspection
Utilized optical gaging products (OGP) systems to conduct precise dimensional inspections and ensure product quality
Utilizing advanced inspection equipment to reduce defect rates through meticulous testing
Review batch documentation, data, certificates of analyses, and technical reports providing support to Quality Disposition personnel
Supervised rigorous air particle analysis to maintain cleanroom standards, ensuring compliance with ISO 14644 and enhancing over product quality
Evaluate batch manufacturing records to determine assurance of safety, identity, strength, quality, or purity
Conducted hydrostatic testing to ensure compliance with specifications and regulatory standards, guaranteeing the safety and reliability of pressure systems
Spearheaded root cause analysis, swiftly inefficiencies to minimize production downtime
Managed equipment calibration records, ensuring compliance with industry standards
Implemented and optimized quality control procedures, improving process efficiency by 30% and project timelines
Collaborate with production to resolve equipment and process issues
Quality Assurance
Yano Consulting Services
07.2021 - 11.2022
Collaborated with cross functional teams to identify and resolve issues, resulting in tremendous improvements
Managed records and files, related to QA issues, escalating them to the necessary parties for resolutions
Assisted in implementing and enhancing both existing and new quality systems in collaboration with the quality management
Assisted in developing and reviewing standard operating procedures, to ensure compliance with quality standards
Support, approve and review all deviations and change controls
Maintained accurate and detailed documentation relations to quality assurance activities
Implemented quality assurance processes to consistently deliver high quality solutions
Performed employee training audits and worked with managements to resolve findings in different departments
Quality Assurance Intern
Advancement Office
05.2019 - 06.2021
Monitored and reviewed customer feedback and complaints, facilitating discussions on root cause analysis
Participated in business requirements reviews to develop functional testing criteria for reports
Actively involved in daily stand ups and sprint planning meetings, providing updates on work procedures and progress
Assisted QA and other departments in preparing for regulatory audits
Developed and maintained quality documentation, ensuring compliance with industry standards
Assisted in planning and prioritizing the team’s feature backlog
Strategically analyzed data for prospective and organized information for creating prospect summaries using MS Office Suite Tools
Conducted research on potential prospective donors that could collaborate with UMass Dartmouth
Education
Bachelor of Science - Management, Operations
University of Massachusetts
Dartmouth, Massachusetts
05.2022
Skills
Quality Management Systems
Continuous Improvement
Aseptic Techniques & Gowning
Quality Standards Adherence
Batch Record Review & Release
Trackwise and SAP Experience
Cross-Functional collaboration
Non-Conformance Reporting
Equipment calibration & Validation
Operational Auditing
Contamination Control Monitoring
Root Cause Analysis
Root Cause Analysis and Prevention
Veeva System Experience
Timeline
Quality Assurance Operations
JVT Advisors
10.2024 - 04.2025
Quality Assurance
Trelleborg Medical Solutions
11.2022 - 10.2024
Quality Assurance
Yano Consulting Services
07.2021 - 11.2022
Quality Assurance Intern
Advancement Office
05.2019 - 06.2021
Bachelor of Science - Management, Operations
University of Massachusetts
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