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Quality Control Assurance

San Diego, California, 92129, United States
March 15, 2011

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Igor R. Chepak

***** ****** *********** ****. #**

San Diego, CA 92129

Phone 858-***-****



Seeking a position of a Material Management or QC/QA specialist where my

previous experience and education will be utilized to achieve rewarding and

long-term growing opportunities.


Significant work experience in the GMP / FDA regulated

Pharmaceutical/Manufacturing and Biotech industry, including over 8 years

of experience in QA/Quality Control departments, Manufacturing and

Material Management, Knowledge of Pharmaceutical (21 CFR 210 & 211) and

cGMPs and cGLPs. Wide experience in a project management, inventory control

& warehouse operations.


NOVEN Pharmaceutical Inc. (former Hisamitsu Pharmaceutical, Inc.),

Carlsbad, California August 2005 - October 2010

QA/QC, Material Management Specialist

Performing variety of activities in QA/QC for supporting and implementing

Quality Systems. Interacting with variety of stuff and departments within

company and contact person for customers.

. Responsible for aiding in regulatory compliance with: FDA GMP's, DEA and


. Responsible for implementing and maintaining a compliant Quality System

per FDA and ISO requirements;

. Support manufacturing operations by coordinating/providing a

manufacturing QA presence to facilitate the initiation and closure of

NCMRs, deviations, and other quality support as needed;

. Perform the Quality Assurance function with the independence and

authority to ensure quality processes and products;

. Serve as the quality control function for routine product release;

. Using JD Edwards software for ordering and maintenance Material


. Ordering, receiving and handling of GMP materials: contacting

customers, preparing and placing material orders, contact person

between company and customers, maintaining Receiving Logbook and


. Performing sampling of quarantine material for Quality Control testing;

. Handling Material Specification Reports: initiating and filling out

MSRs, preparing Approved, Rejected, etc. stickers and labeling

material according to assigned status;

. Releasing and delivering material to appropriate departments; stoking,

organizing and transaction of material to appropriate areas;

. Inventory: maintaining Inventory Logbook and system, verifying material

and FIFO system in Warehouse;

. Experience in coating processes; experience with solvents.

. Designing, reviewing and revising SOPs for the department;

. Personnel training for procedures and policies of the Material

Management department

Neo-MPS, Inc. (Former Multiple Peptide Systems), San Diego, California

May 2000 - August 2005

Quality Control Raw Materials Chemist II

. Performed QC testing of In-Process, Final Product, Raw Material and

R&D samples with the following methods/equipment:

V Chromatography (HPLC), UV-spectroscopy

V Melting point, specific gravity and density

V Optical Rotation


V pH testing

V Amino Acids Analysis

V Peptide MS Sequencing

. Maintained USP Purified Water System (water testing),

. Handle hazardous materials,

. Managed database of lab tests and results,

. Trained and managed new employees,

. Created draft documents for manufacturing and testing procedures.

Scantibodies Laboratory Inc., Santee, CA 1998 -


Chemist, Bulk Serum Production and Immunochemistry Department

. Performed various techniques in filtration, including but not limited


( Custom production of Monoclonal antibody (in vivo)

V Diafiltration by dialysis

V Concentration and dilution of serum

V Resin ion exchange

V Bacterial plating formulation of multiple solution


. Applications of preparative and analytical HPLC mechanisms

. Handling paperwork with FDA regulations compliance and European

manufacturing procedures (ISO 9001)


JD Edwards Training at Noven Pharmaceutical Inc

Good Manufacturing Practice (cGMP), 2004 UCSD, San Diego, CA


State Medical University, Lviv, Ukraine1979-1985: MD

Professional Societies: Member of SDRAN (San Diego Regulatory Affairs


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