Quality Assurance Medical Device

Carlos H Luna

***** ** **** ** ** Doral, Florida 33178 Cell: 305-***-**** jgiqwu@r.postjobfree.com

OBJECTIVE

• To use my skills and knowledge as a Chemist or Equipment

Instrumentations to Pharmaceutical, Medical Device or Environment Company

inside or outside of work station, in a Quality Control or Quality Assurance Lab with

GLP, GMP and FDA Regulations.

EXPERIENCE

IMPEX OF DORAL DORAL, FL (03/2012 – 07/2012)

Chemist II

Wet Chemistry: Testing: Raw Materials, Capacity, Retention, Standard Deviations,

Concentrations and Humidity.

GAM’S DORAL, FL (01/2010 - 02/2012)

Chemist II / Instrumentation/Metrology

Prevent Maintenance, Calibration’s and Troubleshooting Operations for all

Instrumentation such as HPLC, “DISSOLUTION BATHS” (expert), IR, UV/VIS, Polari

meters, Ovens, Karl Fisher, pH, balances, Spectrophotometers, IQ,PQ,OQ, and other

Equipment’s, used in QC lab at different Pharmaceuticals

TEVA PHARMECEUTICAL DORAL, FL (08/2001 - 12/2009)

Chemist II

Wet and Volumetric Chemistry: Testing Raw Materials such as ROI, LOD, Heavy

Metals, Tap and Bulk Density, Melting Point, Karl Fisher, pH, Viscosity, Particle Size,

TLC, Conductivity, Specify Gravity, assaying Small and large test Pharmaceutical

Drugs, and others.

Finish and Stability Products:

• Analysis of Dissolution (Drug Release) for solid dosage. Also analysis of the

preparations using HPLC and UV techniques.

Other tests for Finished Product and Stability, such as Potency, Content Uniformity, and

Related Compounds.

• Following Procedures such as SOP, In House Methods, Pharmacopeias, USP,

JP, EP with GMP, GLP which are all compliant with FDA regulations.

Carlos H Luna

10813 NW 53rd RD LN Doral, Florida 33178 Cell: 305-***-**** jgiqwu@r.postjobfree.com

• Instruments used for analysis such as: Balances, Dissolution Baths, Auto

Samples, HPLC, UV/VIS, FT/IR, Ovens, Titrant, TOC, Particle Size, Conductivity Meter,

Karl Fisher, pH meter, Spectrophotometers and others used a High Quality

Metrology Specialist / TEVA

• Write and Execute IQ, OQ, PQ, PROTOCOLS, Performed Prevent

Maintenance, Calibration and Troubleshooting Operations for all Instrumentation such

as HPLC, “DISSOLUTION BATHS” (expert), IR, UV/VIS, Polari meters, Ovens, Karl

Fisher, pH, balances, Spectrophotometers, Balances, Titrant, pH Meters, Ovens, Ro-

Taps, Particle Size, Incubators, Centrifuges, Melting Point, Ovens, Furnaces, and other

Equipment’s used in QC lab.

• Design and Evaluation of Standard Operating Procedures and Controlled forms

to Ensure Compliance with applicable FDA regulations and improve data collection

efficiency.

• Calibration of other laboratory instruments such as Conductivity and Resistivity

Meters, Hygrometers, Sensors, Timers, Thermometers, Apparatus, Ice Point, Heating

Baths, Force Gauges, Torque Meters, Harness Tester, Barometers, Tachometers, Mass

Weights, Blocks, Calipers, Pressures Gauges, Monitors and Temperature Recorders,

Thermocouples, Data Loggers.

SUNILAN PRESS MIAMI, FL (10/1998 - 07/2001)

Press Man

TRIFFTY RENT-A-CAR (Part Time) MIAMI, FL (12/1994 – 11/1999)

Front Desk

ORIGINAL IMPRESSIONS MIAMI, FL (02/1993 – 09/1998)

Assistant Press Man

DRUG GUILD SECAUCOS, NJ (06/1991 – 02/1993)

Dispatcher

• Picked and packed Medicine orders for pharmacies.

LA PRIMAVERA PHARMACY ECUADOR (1983 – 1990)

Owner and Representative

• Expending General Medical Prescriptions for patients Clinics and Hospitals, etc.

Also medical visitor, introducing new pharmaceutical products.

LIFE LAB. PHARMACEUTICALS (Part Time) ECUADOR (1983 –1990)

• Chemist Testing Row Material and Finish Product

Carlos H Luna

10813 NW 53rd RD LN Doral, Florida 33178 Cell: 305-***-**** jgiqwu@r.postjobfree.com

TRAINING

• CHEMIST STATION, EMPOWER, LIMS, Software Essentials of the Quick Start

Interface

• HPLC 1100, 1200 Preventive Maintenance, Dissolutions Baths Calibrations.

• PERKIN- ELMER FTIR SPECTOPHOMETER.

• AGILENT UV/VIS.

EDUCATION

1978-1983 State Guayaquil University Guayaquil, EC

BACHELOR DEGREE IN CHEMISTRY AND PHARMACY

1971-1977 Technical Exp. Carlos Cisneros Riobamba, EC

TECHNICAL INDUSTRIAL MECHANIC

QUALIFICATIONS

• Knowledge in Electronic Equipment.

• General Instrument Troubleshooting.

• Management tools such as Calibration.

COMPUTERS

• Knowledge in Microsoft Office Programs such as Excel and Word.

COMUNICATION

• Fluent in English and Spanish

Carlos H Luna

10813 NW 53rd RD LN Doral, Florida 33178 Cell: 305-***-**** jgiqwu@r.postjobfree.com

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