OBJECTIVE
EMPLOYMENT HISTORY
Quality Compliance Specialist, 2009 - Present
Providing service as Quality Compliance Specialist for the Stryker Puerto Rico Operations facility, Cutters Unit. Tasks include evaluation of product complaints and generation of investigation reports. Develop Risk Assessments, Technical Assessments, and Product Field Action documents. Review and approval of supplier and manufacturing Non-Conformance investigations and reports. Participate in MDR/MDV meetings of reportable complaint events for FDA and other foreign Competent Authorities. Provide Quality Awareness training presentations to manufacturing area personnel.
Validation Specialist, 2004 - 2008
Provided technical support to manufacturing facilities like Janssen, Wyeth, Watson Laboratories, Schering-Plough, Lilly del Caribe, and ICN Pharmaceuticals. At mentioned sites, developed process validation documents, product transfer strategies, qualification protocols, SOP’s, special studies, failure investigations, and CAPA documentation.
Technical Operations Scientist, 2003 - 2004
Coordinate, develop and execute validation projects and special studies for design control, development and process/product optimization. Review and update validation standard operating procedures. Perform and document failure investigations, and provide corrective and preventive action recommendations.
Technical Operations Research Associate, 2001 - 2003
Develop and execute equipment qualifications and process validations for technology transfer of products and processes. Hands-on experience in dry blend, wet granulation, compression, encapsulation and coating processes. Provide technical support to the manufacturing operations in process optimizations, scale-ups, investigations and troubleshooting. Review and prepare standard operating procedures and formulation instructions.
Technical Services Engineer, 2000 - 2001
Develop and execute Installation, Operational, and Performance Qualification documents for the Pathogen Inactivation project. Coordinate and supervise project related manufacturing activities. Provide appropriate training to personnel involved in project activities. Prepare validation project reports within established due dates and in compliance with cGMP regulatory requirements.
EDUCATION
Turabo University, Gurabo
B.S. Mechanical Engineering, 2000
REFERENCES
Available upon request
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