Antonio Santos
Albany,USA
Summary
Results-driven Quality Engineer with a proven track record of driving continuous improvement initiatives. Committed to fostering the corporate mission, focused and diligent in approach. Recognized for implementing actionable initiatives that reduce error rates and optimize company processes.
Overview
17
17
years of professional experience
Work History
Quality Engineer
Angelini Pharma
01.2024 - Current
- Reviewed of change controls, validation protocols including CSV and reports for process improvement projects
- Implemented supplier qualification follow ups, elevating quality of incoming materials and components.
- Contributed to root cause analysis to determine core reason for failures and errors.
- Provided support during the brainstorming sections for process improvement projects
- Enhanced product quality by implementing testing protocols that addressed previously undetected issues.
- Conducted regular compliance audits, ensuring adherence to industry regulations and standards.
- Fostered culture of continuous improvement, encouraging innovative solutions to quality challenges.
- Collaborated with R&D to integrate quality considerations into early design stages, enhancing product durability and functionality.
- Analyzed and interpreted data to identify trends and recommend improvements.
- Designed and implemented quality control processes to facilitate customer satisfaction.
- Developed and maintained relationships with suppliers to facilitate quality and timely delivery of materials.
- Developed action plan for company certification using ISO 9000 standard knowledge.
- Conducted detailed audits to ensure adherence to ISO 9001 standards, maintaining a high level of compliance throughout the organization.
Process Technology Specialist
Angelini Pharma
04.2020 - 12.2023
- Performed product performance qualifications protocols, and reports to support manufacturing processes in a timely manner
- Executed process improvement initiatives through the change control process according to projects timelines.
- Completed CAPA records and product investigations according to the regulation's timelines.
Sr. Technical Services Scientist
GSK Consumer Healthcare
08.2019 - 03.2020
- Performed troubleshooting and assisted in leading initiatives to solve challenging scientific problems with assays or instrumentation.
- Trained new employees on areas of technical expertise and compliance issues relevant to lab setting.
- Performed process validations, equipment qualification and investigation report writing related to Medical Device facility
Sr. Technical Services Scientist
Pfizer Consumer Healthcare
08.2014 - 08.2019
- Performed process validations, equipment qualification and investigation writing reports related to Medical Device facility
- Implemented quality control measures to ensure the accuracy and reliability of experimental results.
- Simultaneously managed several complex projects, meeting all pertinent milestones.
Technical Services Specialist
Amgen Inc
08.2013 - 04.2014
- Performed Product Performance qualification in the filling area of parental products as a part of product transfer to the new facility
- Completed validation protocols and reports
- Performed Media Fills as a part of the new facility qualification
Technical Services Specialist
Pfizer Pharmaceutical LLC
02.2012 - 06.2013
- Performed validation and special projects for drug product area (Solid Dosage)
- Executed supplier qualifications and process validation as a part of process improvements initiatives
- Provided training to manufacturing area personnel related to sampling and validation activities
- Performed changes to manufacturing batch records related to process improvements
- Performed data analysis using six sigma tools and reduce the variability of the process as part of manufacturing studies
- Completed manufacturing investigation using DMAIC methodology to identify root cause and effective CAPA
Statistics and Validation Scientist
Abbott Diagnostic International LTD
01.2008 - 05.2011
- Provided process development, validation, statistical and technical support to product manufacturing with adherence to GMP, ISO Standards and OSHA procedures
- Supported and perform product transfer and its associated activities including training in new procedures, documentation and implementation of new processes, new test methods and validation
- Identified and formulate action plans to resolve validation issues
- Analyzed and develop product specifications according to division procedures
- Reviewed, change and write product related documentation
- Provided statistical support to product Scientists in the resolution of technical issues
- Participate in all activities related to Abbott Diagnostic International products transfers to North Chicago Facilities
Education
Master of Science - Public Health Education
University of Puerto Rico,
Medical Science Campus, PRBachelor of Science - Industial Microbiology
University of Puerto Rico
Humacao, PRSkills
- Comprehensive Documentation
- Analytical Decision-Making
- Six Sigma Practices
- Validation of Testing Procedures
Accomplishments
· Production Materials: Top contributor of the team that led a project that resulted in a 50% reduction in materials expenses saving the company $500,000 annually.
· Secondary Packaging Optimization: Top contributor of the team that implemented carton size reduction that resulted in 20% in material cost saving the company $340,000 annually.
· Packaging Materials: Top contributor of the team that implemented new carton material that resulted in 40% in cost saving the company $600,000 annually.
Languages
English
Native or Bilingual
Spanish
Native or Bilingual
Timeline
Quality Engineer
Angelini Pharma
01.2024 - Current
Process Technology Specialist
Angelini Pharma
04.2020 - 12.2023
Sr. Technical Services Scientist
GSK Consumer Healthcare
08.2019 - 03.2020
Sr. Technical Services Scientist
Pfizer Consumer Healthcare
08.2014 - 08.2019
Technical Services Specialist
Amgen Inc
08.2013 - 04.2014
Technical Services Specialist
Pfizer Pharmaceutical LLC
02.2012 - 06.2013
Statistics and Validation Scientist
Abbott Diagnostic International LTD
01.2008 - 05.2011
Master of Science - Public Health Education
University of Puerto Rico,
Bachelor of Science - Industial Microbiology
University of Puerto Rico
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