Quality Assurance Six Sigma

MD KARIM

Email: abqsxn@r.postjobfree.com

Address: **** ***** **, *** # **

City: BALTIMORE

State: MD

Zip: 21225

Country: USA

Phone: 801-***-****

Skill Level: Experienced

Salary Range: $60,000

Willing to Relocate

Primary Skills/Experience:

See Resume

Educational Background:

See Resume

Job History / Details:

Md. Karim

2210 Round Rd, apt# T2 * Baltimore * MD 21225

801-***-**** * abqsxn@r.postjobfree.com

summary of qualifications

Master's degree in Biomedical Engineering, Bachelor's in Microbiology, quality assurance/ quality control lab manager for five years, five years research experience in Life Science, experience in several skills including Statistic Analyzing, Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Standard Operating Procedure (SOP), Quality System Regulation (QSR), documentation, HPLC, Gas chromatography-mass spectrometry (GC-MS), Plating, Staining & Growing Bacteria, Aseptic techniques, Sterilization, Real Time/RT-PCR, DNA/RNA/Protein Isolation, Purification and Analysis, Molecular cloning, Cell Culture, Elisa, Western Blot, Wet chemistry, Lab Management, Project Management, Six sigma Green Belt Certification, Certificate Quality Engineer (CQE), ISO-9001 and FDA regulations. Excellent computer skills including, Microsoft Office (PowerPoint, Excel, and Word).

Work

QUALITY ASSURANCE LAB MANAGER

Corning, Salt lake City, UT July2010 - November 2012

Identifying and implementing process improvement initiatives that improve workflow and productivity using Six Sigma technology, Excel, Mini-tab and so on

Supervise QA techs and acting as an advocate and an auditor for GLP/GMP practices in the lab as well as in the floor.

Leading and investigating quality issues including that may arise, reporting them to management, implementing corrective action and preventive action (CAPA) and identifying departmental strengths and weaknesses.

Ensure compliance with quality system regulation (QSR) and standards agencies regulations and guidelines- including documentation, ISO-9001, FDA, CLSI and company's Standard Operating Procedure (SOP).

Validate the proper gama radiation dosage using Method 1 Validation of Radiation Sterilization of the Associate for

Advancement of Medical Instrumentation (AAMI).

To certify the products regarding DNA free, DNA inhibitor free, ATP free (Adenosine Tri-Phosphate), Dnase/ Rnase free and Pyrogen free; several bio-molecular assays study were performed and monitored including Bioburdon, Limulus amebocyte lysate (LAL), Sterility,UV/VIS spectrophotometer, PCR and Gas chromatography-mass spectrometry (GC-MS).

Testing raw materials and finish goods using FTR, TC plate, refractometer, viscosity, titration, dry content, PH meter, sterile water using Ozone and UV combination, air quality monitor and so on.

RESEARCH TECHNOLOGIST- ENVIRONMENTAL HEALTH SCIENCES February 2009- June 2010

Johns Hopkins University, Baltimore, MD

Investigated risk factors (aflatoxin and HBV) relate to liver cancer in Shanghai, China population. Several protocols

Had been followed including

In vitro diagnostic of medical devices- calibration, sterility, PCR/ Real time PCR, cell culture, fermentation and so on.

DNA isolation from human serum and Picogreen to measure DNA concentration.

Real Time PCR/ PCR to investigate the mutation in codon 249 of the TP53 gene & quantify Line1 DNA in cancer patients

Followed GLP, GOP, SOP and FDA roles and regulations.

RESEARCH ASSISTANT - IMMUNOLOGY & MICROBIOLOGY DEPARTMENT Wayne State University, Detroit, MI January 2008 - January 2009

Performed Plating, Staining and Growing Bacteria for quality control and research purposes.

Performed Methyl-Thiazolyldiphenyl Tetrazolium Bromide (MTT) Colorimetric Assay to evaluate the proliferation of RAW264.7 Murine Macrophage Cells in culture medium containing different concentrations of Biomaterials. PCR and Gel Electrophoresis are used to understand the Gene Expression of Microphage.

Read and followed SOPs and Protocols, as well as following Good Manufacturing Practices (GMPs) & Good Laboratory Practices (GLPs) and managed the Lab.

Md. Karim

Page 2

RESEARCH ASSISTANT - DEPARTMENT OF MOLECULAR & MICROBIOLOGY

Brigham Young University, Provo, UT August 2005- August 2006

Investigated the inactivation of Prion Infectivity by Reactive Oxygen Species (ROS). Our research group was able to

eliminate Prion infectivity by a precise measured dose of Ozone. To accomplish this study, following procedures had been

performed

Cell Culture (Vero, Raji, & Jurkart, N2a).

Ozonated N2a cells at 1200 ppmv for 1 hour by a bio-instrument developed by the Lipidviro Tech Inc.

Digested non-infectious Prion with Proteinase K.

Assayed for infectious Prion with Cell and Western Blots.

Performed internal affair, document control, SOP, sterilization and soon.

RESEARCH ASSISTANT - DEPARTMENT OF MOLECULAR & MICROBIOLOGY

Brigham Young University, Provo, UT September 2002- April 2005

Performed Western Blots Analysis and Protein Isolation to study the RecA Protein Expression.

Performed PCR to amplify the rRNA gene to study the 16S-like rRNA Expression in different plants.

Completed RNA Isolation and Northern Blots Analysis to measure 23S rRNA Expression in different plans.

Achieved Chloroplast and Mitochondrial DNA Isolation and Purification from Arabidopsis, Soybean and Turnip plants .to study the DNA Recombination and Replication using HPLC.

Planted and harvested seeds, sterilized lab products and follow GOP/GLP.

LAB ASSISTANT -DEPARTMENT OF FOOD SCIENCE

Brigham Young University, Provo, UT April 2004 - April 2005

Checked the bacterial present in samples including hamburger patties and ice-cream using Elisa Assay and Rapid Test.

Made plates and seeded the plates with diluted samples to check bacterial present including Salmonella, E. coli 0157 etc.

Kept proper documentation for QA/QC purpose.

Maintained internal procedures and supporting SOP documents.

Education

Master of Science in Biomedical Engineering August 2009

Wayne State University, Detroit, Michigan

Bachelor of Science in Microbiology - Minor, Chemistry August 2006

Brigham Young University, Provo, Utah

Six Sigma Green Belt Certification August 2009

Wayne State University, Detroit, Michigan

Certificate Quality Engineer (CQE) Sept 2012 - present

American Society of Quality (ASQ)

Radiation Safety Certificate

Brigham Young University, Provo, Utah May 2005

relevant skills

Experimental Design UV/VIS spectrophotometer

PCR, RT-PCR & Gel Electrophoresis Project Management

Western Blot Lab Management

Cell Culture FDA regulations

DNA/ RNA/ Protein Isolation, Purification and Analysis Six Sigma Green Belt Certification

Molecular Cloning Word Perfect 6.0

Quantity & Quality Analysis Chemistry Microsoft Office (PowerPoint, Excel, and Word)

HPLC and GC-MS Computer Programming (JAVA, Math lab)

extracurricular activities

Poster Presentation - American Society for Biochemistry and Molecular Biology April 2005

San Diego, CA

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