Emmanuel Ortiz Millan
Caguas,PR
Summary
Dynamic Quality Assurance Analyst successfully executes testing methodologies to identify gaps and make recommendations for process improvements. Leverages excellent analytical and programming skills to document and troubleshoot errors. Advanced knowledge of test case management and defect tracking tools to support test processes. Demonstrated success in public health project and team management, including epidemiology, statistical analysis and literature reviews. Skilled in technical writing, surveillance and field research. Results-driven and proactive with a diligent, responsive and resourceful nature. Experienced in promoting health of diverse populations, preventing diseases and optimizing current tracking, assessment and containment programs. Motivated to strengthen responses by thoroughly analyzing and interpreting data. Subject matter expert in diseases.
Overview
10
10
years of professional experience
Work History
Quality Assurance Analyst
Janssen Ortho
Gurabo, PR
11.2013 - Current
- Supported company in maintaining work environment focused on quality, communication, collaboration, integration and teamwork.
- Maintained knowledge of regulatory requirements, to include accrediting bodies, federal, state and local requirements, as well as Janssen's policies.
- Inspected work areas regularly to identify safety practices, quality control procedures and worker actions in need of improvement.
- Verified manufacturing team's compliance with quality control processes to help minimize rework and keep costs low.
- Compiled clinical research data into audit reports and shared with research teams and lead investigators.
- Completed timely quality reports highlighting deficiencies and recommending corrective actions.
- Identified issues of non-compliance and elevated reports to senior personnel.
- Determined correct procedures for inspection and review to standardized audit processes.
- Completed deviation forms and recorded findings of inspection process, collaborating with quality team members and department managers to implement procedural remedies.
- Provided analytical, planning and coordination support on projects as assigned, reviewing, interpreting, analyzing and illustrating data to stimulate and support enlightened decision making.
Education
Master in Public Health -
San Juan Bautista
Caguas05.2015
Bachelor of Science -
Sagrado Corazon
San Juan05.2013
Skills
- Hardware development
- Testing plans
- Web platform development
- Technical Analysis
- Group presentations
- Data Analysis
- Data Validation
- Quality Management
- Project Management
- FDA regulations
- Process implementation
- Quality assurance
- Root Cause Analysis
- Correction action planning
- Continuous Improvement
- Quality Control Processes
- Product Quality Requirements
- In-Process Inspection
- Raw Materials Review
- Standards Compliance
- Computer knowledge
- Computer skills
- Research expertise
- Program analysis
- Paper presentation
- Prevention strategies
- Leadership
- Community-based resources
- Public outreach
- Teamwork
- Microsoft Office
- Written Communication
Timeline
Quality Assurance Analyst
Janssen Ortho
11.2013 - Current
Master in Public Health -
San Juan Bautista
Bachelor of Science -
Sagrado Corazon
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