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Quality Control Technical Support

Location:
Pompano Beach, FL
Posted:
January 25, 2016

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Resume:

Giovanni M. Casanova

**** ****** *** ****, ***** Springs, FL 33067

954-***-**** • acs862@r.postjobfree.com

QUALITY CONTROL CHEMIST

PROFILE

Solutions-focused, motivated professional with a comprehensive background in quality control, specializing in the pharmaceutical industry. Ability to manage multiple simultaneous projects while working under pressure in deadline-driven environments. Highly versatile; quickly masters new roles, responsibilities, technologies and situations. Reputation for integrity, problem solving abilities, work ethic and analytical skills.

CORE COMPETENCIES

Chemical & Physical Testing • SOP/STP • cUSP/NF • QA/QC • R&D

Safety Conscious • FDA/cGMP Compliance • GLP/GDP • Staff Training

Creative Problem Solver • Attention to Detail • Mathematical Skills

EDUCATION

Bachelor of Science in Chemistry - Magna Cum Laude - GPA (3.85/4.00)

Florida Atlantic University, Boca Raton, FL 2013

Directed Independent Study:

Organic Reactions Mediated By Sulfidic Carbonate and Clay Depositions.

Advisor: Dr. J. W. Louda

PROFESSIONAL EXPERIENCE

ECI Pharmaceuticals, Fort Lauderdale, FL

Quality Control Chemist II ( 12/2013 - 10/2014 )

Quality Control Stability Chemist ( 10/2014 - Present )

Selected Highlights:

Coordinate stability operation activities and ensure quality products and systems.

Monitor stability chambers and chart recorders on a daily basis to confirm environmental conditions for acceptance with established specifications.

Determine stability sample requirements, develop stability protocols and oversee execution of stability protocols

Prepare stability data graphs to estimate expiration dates and verify product shelf life by evaluating stability trends.

Analyzed stability samples in accordance with standardized testing procedures

Initiated action reports or deviation reports for any applicable nonconformance.

Work closely with QC supervisor regarding stability testing scheduling and assignments

Provided technical support for analytical instruments such as GC/HPLC, UV/Vis, FTIR, Dissolution, etc.

Transferred test methods between analytical labs and verified USP methods.

Developed and validated new test methods

Generated and reviewed standard operating procedures and standard test methods.

Analyzed raw materials, in-process materials,finished products and stability samples in accordance with standardized testing procedures or cUSP/cNF monographs.

Conducted OOS/OOT laboratory investigations and reported outcome.

Implemented cGMP requirements as well as maintained a clean laboratory environment.

Assisted in training Laboratory technicians and entry level Chemists.

Reviewed laboratory notebooks promptly and accurately.

Tarmac Products Inc, Miami Lakes, FL

Quality Control Analytical Chemist (04/2013 - 12/2013)

Selected Highlights

:

Performed analysis of raw materials, stability samples, accelerated formulations, in-process and finished products using cUSP and in-house testing methods utilizing HPLC,GC,UV/Vis & FTIR on a daily basis.

Wet chemical testing such as titrations, Karl Fischer, pH analysis and identificaton tests.

Calibration of analytical equipment such as the balance, pH meter, HPLC, GC, and spectrophotometers.

Responsible for writing and executing method validation protocols and reports for method validation and analytical test methods for cleaning samples.

Responsible for analytical method development and validation for products to be manufactured.

Carry out troubleshooting of analytical equipment, as well as preventive maintenance.

Good documentation practices on QC logbooks and QC laboratory notebooks to be cGMP compliant.

Organic Geochemistry Group @ Florida Atlantic University, Boca Raton, FL

Research Assistant (08/2012 - 12/2013)

Applied lab expertise toward proactively supporting staff members in all aspects of research and development tasks, including preparing test samples, determining pH, and identification using FTIR and UV/Vis spectroscopy.

Selected Highlights:

Prepared solutions, mobile phases, and equipment to support staff scientists.

Demonstrated critical thinking skills in analyzing findings and utilizing results to recommend ideas for further testing.

Analysis of samples by HPLC and UV/Vis.

INSTRUMENTATION/SOFTWARE

Perkin Elmer

Series 200 High Performance Liquid Chromatograph (TotalChrom)

Autosystem XL Gas Chromatograph (TotalChrom )

Headspace Autosampler HS-40

Clarus 580 Gas Chromatograph-Mass Spectrometer (TotalChrom )

Spectrum RX/One FT Infrared Spectrophotometer ( Spectrum )

Lambda 25/40 Ultraviolet Visible Spectrophotometer ( UVWinlab )



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