Maintenance Quality
Resume:
Luis E. Bayon
Jersey City, New Jersey, 07307
Home Phone 201-***-**** Cellular: 201-***-****
Email: *********@*****.***
OBJECTIVE: To seek a responsible position in R & D / QC / QA /Analytical Method
Development laboratory of a food or pharmaceutical organization.
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STRENGTHS:
Theory, operation, troubleshooting and maintenance of Chromatographic and Spectroscopic instruments
Understanding and Practice of cGMP, SOP, and FDA Guidelines
Highly motivated and result oriented professional with strong analytical and team building skills
Ability to manage multiple projects at the same time
Can recognize important issues, make effective plans, get resources in place to achieve key objectives
Ability to convert technical skills into practical applications
Results oriented, with ability to efficiently resolve operational problems
Demonstrate flexibility to accommodate changes in activities
Excellent computer skills in Word, Excel and Power point, Oracle
Bilingual Spanish & English
Quick learner, willing to maintain current up-to-date job knowledge & skills
EDUCATION:
New Jersey City University
Degree: BS in Chemistry, Spring 2003
EXPERIENCE:
07/06/10 - 01/06/2012 Frutarom USA Inc
Regulatory Specialist
Description - Ensure all documentation and regulatory submissions are prepared to meet global regulatory standards and provide information for US and worldwide submissions.
Experience working with flavors, aroma chemicals, gums and extracts
Work with Kosher entities to comply with their standards.
Submission of DEA applications and forms
Work with QA, QC and Manufacturing to assure that all regulatory requirements are met.
Responsible of creating (Specs, MSDS, and other regulatory requirements of the company )
Guarantee that all raw materials and finish products are in compliance with customers requirements (Natural U.S/EU, Origin, Source, Non GMO, and Non allergenic, etc)
04/03/06 – 07/02/2010 Advanced Biotech
Regulatory Specialist
Description - Ensure all documentation and regulatory submissions are prepared to meet global regulatory standards and provide information for US and worldwide submissions.
Work with QA, QC and Manufacturing to assure that all regulatory requirements are met.
Responsible of creating (Specs, MSDS, and other regulatory requirements of the company )
Guarantee that the raw materials are natural botanical, non GMO, and non allergenic.
Work with Kosher Certificates and regulatory standards.
Chemist
Operation, troubleshooting and maintenance of Chromatographic and Spectroscopic instruments
( FTIR, UV, and GC/GCMS )
Performed physical, routine and advanced analytical testing to establish quality of incoming raw materials
Perform routine testing of all safety and calibrated equipment
10/14/2005 –03/18/2006 Genzyme ( Biochemical Center )
Analyst II (Q.C. Lab)
Performed physical, routine and advanced analytical testing to establish quality of incoming raw materials
Operation, troubleshooting and maintenance of Chromatographic and Spectroscopic instruments
( FTIR, UV)
Calibration of equipment ( PH Corning M250 ) and Osmometer.
05/12/2005 - 10/12/2005 Rhodia ( Research Center )
Research Assistant / Oil field group
Performance testing of surfactants and polymers, wet chemistry, rheology measurements with Fann 50, Fann 35 and Brookfield viscometers
Formulate and develop of viscoelastic surfactants
Rheology and hydration studies for application in the oil field
Determine surface and interfacial tension of surfactants
Perform routine testing of all safety and calibrated equipment
Maintain record keeping
07/2004 – 05/2005 Pharmaceutical Innovations
Junior Chemist
Performed physical, routine and advanced analytical testing to establish quality of incoming raw materials
Batch maker within cGMP environment
Control of technical documentation regulated by FDA and ISO
REFERENCES: Available upon request
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