Quality Control Assurance

Igor R. Chepak

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

San Diego, CA 92129

Phone 858-***-****

E-mail: *******@*****.***

OBJECTIVE

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.

QUALIFICATIONS SUMMARY

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.

EXPERIENCE

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

ISO

. 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

Inventory;

. Ordering, receiving and handling of GMP materials: contacting

customers, preparing and placing material orders, contact person

between company and customers, maintaining Receiving Logbook and

system;

. 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 MS-LCQ

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 -

2000

Chemist, Bulk Serum Production and Immunochemistry Department

. Performed various techniques in filtration, including but not limited

to

( 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

reagent

. Applications of preparative and analytical HPLC mechanisms

. Handling paperwork with FDA regulations compliance and European

manufacturing procedures (ISO 9001)

COURSES:

JD Edwards Training at Noven Pharmaceutical Inc

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

EDUCATION:

State Medical University, Lviv, Ukraine1979-1985: MD

Professional Societies: Member of SDRAN (San Diego Regulatory Affairs

Network)

Contact this candidate