Quality Control Assurance

Mila Pylneva

** ********* *******

Hillsborough, NJ 08844

Tel: 908-***-**** E-mail: ********@*****.***

OBJECTIVE

Seeking a challenging Clinical Research Associate position in the

Pharmaceutical field to purposefully utilize my qualifications.

Therapeutic Areas of Experience:

. Endocrinology: Diabetes Phase II,

III

. Analgesia: Pain

Phase III

. Cardiology: Hypertension Phase II,

III

. Musculoskeletal: Osteoarthritis Phase III

EXPERIENCE

Clinical Research Associate

GlaxoSmithKline

04/2008 - present

. Coordinate and perform all aspects of clinical monitoring in

compliance with FDA regulations, ICH/GCP guidelines and SOP's.

. Conduct site visit, including Pre-study visits, Initiation visits,

Monitoring visits, Close Out visits.

. Evaluate protocol and regulatory compliance; ensure integrity of

study data is accurate and complete.

. Perform Source Data Verification.

. Review consent process for each subject (Informed Consent Form and

source documentation).

. Perform CRF review/retrieval.

. Perform Drug accountability.

. Oversee maintenance of on-site investigator files, IRB

documentation, Local laboratory documentation.

. Verify receipt of investigational supplies and equipment at sites.

. Track Adverse Events; ensure serious adverse event are recorded and

reported.

. Attend Investigator meetings.

. Prepare Monitoring trip reports in a timely fashion.

R&D Research Scientist I

AZ Electronic Materials USA Corp, Somerville, NJ

09/2002 - 04/2008

. Manage daily operation of the projects for raw material evaluations,

process optimization, provided support on formulation preparation,

wafers processing, and characterization of multilayer materials.

. Conducted lithographic evaluation and compiled data packages in

assisting multilayer product development.

. Wrote final reports and made presentation for each project to a large

audience.

. Clean room and Chemical lab experience using coating, exposure,

developing, measurement tools (ACT-12, Teltrack, Nicon, Optitrack,

ASML, Ultratech stepper, NANO9000, FT-IR, KLA2300, VWV2000).

Quality Assurance/Quality Control Technician-3

JDSU, Piscataway, NJ

08/1998 - 05/2002

. Conducted pre-cap visual inspection after each step of the assembly

process; final inspection boards before capping, inspection all

incoming parts and calibration.

. Internal visual inspection following circuit's assembly and circuit's

integration.

. Incoming FET inspection and testing.

. Return material analyzing, documentation, inspection, and control.

. Maintain QA/QC logs, documentation, calibration all equipment.

Wafer Fab-Material Processing Technician-2

ANADIGICS, Warren, NJ

07/1996 - 08/1998

Operated various machines including Rapid Thermal Annealer, Reactive

Ion Etching System, Eaton NV-6200 AV ion implantation system,

Heatpulse 2101 Ohmic Alloy operation.

QA/QC inspector

ASTROLAB, Warren, NJ

01/1994 - 07/1996

Conducted quality control and QA inspections of cables and connectors.

EDUCATION

Masters Degree, Chemical Engineering

Azerbaijan Polytechnic University, Baku, Azerbaijan

Clinical Research Associate Certificate

Chiron Training Center, Jersey City, NJ

Medical Administrative Assistant Certificate

The Cittone Institute, Edison, NJ

AutoCAD-13 Certificate

Somerset County Technical Institute, Bridgewater, NJ

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