Quality Control Manager

ESTHERGALVEZ

***** ** **** **** ****: 305-***-****

Miami, FL 33175 Cell: 305-***-****

Email: ******.********@*****.***

SUMMARY

Highly motivated Quality Control-Compliance Professional with extensive

experience auditing laboratory data for Raw Materials, In-process, and

Finish products. Detail oriented team-player; successful effective trainer,

able to coach co-workers in technical support processes. Experienced in

chemical In-House and USP procedures and instrumentation. Knowledgeable in

Regulatory Compliance, FDA, DEA, EPA, and cGMP regulations and guidelines.

Total integrity in handling sensitive and confidential information.

Bilingual (English and Spanish).

PROFESSIONAL EXPERIENCE

TEVA PHARMACEUTICALS USA 6/1999 - 12/2009

(Formerly IVAX PHARMACEUTICALS, INC.), Miami, FL

A global Israeli based pharmaceutical company, leader in the global

Generics industry.

Compliance Associate - Quality Control (2006 - 2009)

Auditing laboratory data using LIMS, Empower, and Total Chrom software.

Generated Certificate of Analysis. Released Raw Materials lots. Changed raw

material status using JDE and ORACLE. Preparation of labels for Raw

Materials drums in the warehouse. Cleaning Validation: reviewed swabs data

for manufacturing and packaging equipment. Followed cGMP procedures in a

regulated industry and ensured that current procedures and analytical

methods are being followed.

. Coordinated the team in the absence of the Supervisor or Manager.

Prioritized tasks received in the lab.

Senior Chemist (2004 - 2006)

Supervised, trained and provided technical support to staff chemists in the

Raw Material area. Troubleshooted and resolved problems encountered in

technical procedures used in the lab and suggested corrective actions to

the problems. Product identification by Thin Layer Chromatography (TLC),

Infrared (IR), Qualitative tests. Assay and Impurities by HPLC,

Potentiometric titrations, completes pertinent documentation. Reviewed

notebooks and raw data. Knowledge in all types of compendia testing (USP,

BP) and wet chemistry techniques.

. Resolved an investigation during the technology transfer to Northvale

N.J. with failing particle size distribution testing using The Air Jet

Analyzer. Raw Material: Quinine Sulfate. Trained and coordinate new

employees in the Raw Materials Department.

Chemist II (1999 - 2004)

Maintained and calibrated equipment, ordered reagents and laboratory

supplies as needed. Preparation of test reports. Moisture determination by

Karl Fischer, Water Conductivity. Performed wet chemistry test (LOD, pH,

titrations). Particle size determination and other physical testing.

. Approved instruments needed for Raw Materials Department: Melting Point

Apparatus, PH meter.

DADE BEHRING 8/1991 - 2/1999

(Formerly DADE INTERNATIONAL AND BAXTER DIAGNOSTICS, INC.), Miami, FL

The Company offer products include a variety of diagnostic systems-

integrated chemistry, immunoassay, routine chemistry, automation,

hematology, hemostasis, microbiology, diabetes, urinalysis.

Technical Operations Associate (1995 - 1999)

Performed analysis using qualitative and quantitative methods. Preparation

and presentation of test reports. Performed in process and final product

Quality Control testing. Instrumentation: Clinical: DuPont ACA, TDx.

Modified Standard Operating Procedures as needed.

. Trained co-workers and maintained instruments as needed.

Scientist II (1992 - 1995)

Qualification of Raw materials: Primary antibody. Fertility team: HCG, LH,

Progesterone (antibody titrations). Performed affinity and inhibition

assays. Instrumentation: Electrophoresis (Pharmacia, Beckman, Helena Phase

System). Atomic Absorption Spectroscopy, Flame Photometry.

. Qualified and evaluated primary antibody (LH) saving the lot, and

founding a secondary antibody to match with.

Scientist I (1991 - 1992)

Routine analysis: In process and final product. Troubleshooting of

Analytical Instruments. Instruments: Chloride Analyzer, Stratus, IMX.

. Worked in the Karl Fischer Analyzer qualification.

EDUCATION

Bachelor's Degree, BS in Chemistry

University of Havana, Cuba

Post-Graduate: Research in soil applied to agriculture (General Edaphology)

Soil Institute: Academy of Science of Cuba

Contact this candidate