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Quality Control Project

Location:
Clawson, MI, 48085
Posted:
October 06, 2012

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Resume:

BERNADIT SEMAN

**** ****** **** **. **** Michigan 48085 Tel: 619-***-****

hc5j85@r.postjobfree.com / hc5j85@r.postjobfree.com

EXECUTIVE SUMMERY

Accomplished and integrity driven professional offering over 9 years extensive experience in operations manufacturing pharmaceuticals management. Passionate about quality and customer satisfaction. Record of improving efficiency, productivity, profitability and process improvement. Outstanding interpersonal, motivational and presentational skills. Analytical, articulate and diligent.

CORE COMPETENCIES

Operations Research System Strategic Planning & Execution System Data Analysis

Regulatory Compliance with OSHA, FDA, GLP & SOP Project Leadership & Operation Management Method Development Client Relationship & Management Quality Control Communication & Presentation Proposal Development Process Improvement Extensive Repots Generating Extensive Development Training MS Office (Word, Excel, Spreadsheet & Power Point, Project & Outlook)

ACCOMPLISHENTS

Saved over $50 Million for Neurocrine Biosiences by killing a drug that was thought to have the same effect and behavior as the “mother” drug. It did not when it came to my Pre-Clinical Department after I analyzed data from FDA approved strategic and execution methodologies. Result was, I was awarded a promotion and pay increase.

Saved many thousands of dollars for Neurocrine Bioscience and MicroConstants. Advocated that each organization build an ELISA Lab (Dept.) from my experience acquired at CALBIOTECH INC. and trained each company’s staff on running the labs.

Assigned as a US Army Linguist and Culture Advisor working with commanders and training operations for personnel prior to deployment. As an Experienced tri-lingual and knowledgeable in military terminology, Nipr & Sipr, some war tactics, and ground force missions, assisted The Civil Affairs Department Team, The Human Intelligent Team and The Military Escorting Teams.

PROFESSIONAL EXPERIENCE

Feb. 2011- July 2011 Torres Advanced Solution LLC, Babil PRT, Hilla- Iraq

Linguist/Translator to support State Department Babil PRT Advisors in all aspects of the daily operation in providing general linguistic support for DOS advisors & military operations, interpret during interviews & meetings, conferences Interpret, translate written and spoken communications, transcribe and analyze communications, perform document exploitation Scan, research, analyze foreign language documents for key information, translate foreign language documents Identify and extract information components meeting according to DOS & military information requirements.

Sep.2009- Feb 4,2011, Torres Advanced Solution LLC, ePRT Baghdad- South - Iraq

Linguist/Translator to support State Department PRT Advisors in all aspects of the daily operation in providing general linguistic support for DOS advisors & military operations, interpret during interviews & meetings, conferences Interpret, translate written and spoken communications, transcribe and analyze communications, perform document exploitation Scan, research, analyze foreign language documents for key information, translate foreign language documents Identify and extract information components meeting according to DOS & military information requirements. Specifically about (Women Issues, Agriculture, Role of Law, Health Issue, Essential Services, Governance, USAID, & Economic Development).

Emphasizing work with Women Issues including; Women Organization, Education, Elections, Domestic Violence, Assisting War Widows, Women Agriculture Association. For the last eight months, I worked on the most successful agricultural programs; 4-H Club for Iraqi youths & helping & participating in training & giving Extensive lectures for Dairy Herd Management Class & 4-H Clubs in South Baghdad Areas (AL Mahmudiyah, Al Latifiyah, Al Yousifiyah, and Al Rashid).

April 2008- Sep. 2009, GLS, Baghdad, Iraq, SVT (Strategic Vetting Team), IZ Baghdad, Iraq

US Army Linguist CAT II w/ Final Secret. Supporting Strategic Vetting Team (SVT) providing linguistic to in all aspects of the daily operation in providing general linguistic support for SVT agents & military operations, interpret during interviews & meetings, conferences Interpret, translate written and spoken communications, transcribe and analyze communications, perform document exploitation Scan, research, analyze foreign language documents for key information, translate foreign language documents Identify and extract information components meeting according to military information requirements.& support in all aspects of the team’s operations which includes vetting of various high-ranking Iraqi nationals to sensitive Polygraph Examinations. Participated in polygraph interpretation for over 130 Sessions and translated documents & applications for SVT.

Feb. 2006- March 07, L-3 Communications, (NTC) Ford Irwin, Barstow, CA.

US Army Linguist & Culture Advisor, trained and prepared the psychological operations forces before their deployment to Iraq. Assisting commander officers in the aspects of Iraqi cultures & traditions and offering daily classes.

Jan 2003- Aug.2004, Sr. Research Associate, Bioanalytical Chemistry Pre-Clinical Development Department, Neurocrine Biosciences, San Diego, California

Responsible for Method Development, Sample Analysis, Method Validation and Report Writing for the Determination of Pharmaceuticals in Biological Fluids. Analyses include Liquid/Liquid, Protein Precipitation procedures followed by separation and detection on LC/MS/MS or HPLC systems, performing and developing ELISA Immunoassay, Protein Binding using Spectra/Por Equilibrium Dialyzer. Responsible to provide Bioanalytical Method Development and Sample Analysis supports to all Research and Development Project Programs.

July 2001- Dec.2002, Research Associate, ELISA and Bioanalytical Chemistry, Pre-Clinical Development Department, Neurocrine Biosciences, San Diego, California

Built an ELISA Lab, Responsible for Sample Analysis, Method Validation and Report Writing for the Determination of Pharmaceuticals in Biological Fluids. Analyses include liquid-liquid, solid phase extraction procedures followed by separation and detection on LC/MS/MS or HPLC systems, performing and developing ELISA Immunoassay, ELISA method validation, Protein Binding using Spectra/Por Equilibrium Dialyzer. Also, main responsibilities is providing Bioanalytical Method Development and Sample Analysis supports to all Research and Development Project Programs.

Oct.1999-July 2001: Senior Analytical Scientist, ELISA and Bioanalytical Chemistry, MicroConstants, San Diego, California

Build an ELISA Lab, Responsible for Sample Analysis, Method Validation and Report Writing for the Determination of Pharmaceuticals in Biological Fluids. Analyses include Liquid-Liquid, Acid-Base and Solid Phase Extraction procedures followed by separation and detection on LC/MS/MS or HPLC systems, and performing Immunoassay ELISA Assay, determination of pharmaceuticals, antibody and cytokine levels by ELISA. Established ELISA Department, Helped in creating ELISA SOPs, Created Forms and Report Templates. An additional responsibilities included Data Handling Recording, Report Writing and follow GLP Requirements.

July 1998- Oct. 1999 Research Associate, ELISA Development, CALBIOTECH INC. Spring Valley, CA.

Participate in Building of an ELISA Lab, Performed Research Development & Manufacturing ELISA Kit, Method Validation, Project Organization and Project Data Review. Also, managerial responsibilities for Coating, Filling, and Shipping Departments, as well as Customers’ Affairs.

1996 - 1998 SDSU LAB, San Diego, CA.

Worked in academic and biological research in areas of DNA: Able to perform double and partial digests DNA, DNA sequencing, Southern & Western Blotting PCR, SDS-PAGE, Enzyme Isolation, Gel Electrophoresis and Media preparation.

Jan. 1989 – April, 1989 Intern, Omni Laboratories, Southfield, Michigan

Responsible for Blood Sampling, recording and performing Urinalysis, Hematology, Blood Banking, Analytical Chemistry, and reporting results.

April, 1989 – Jun. 1989 Intern, Detroit Comprehensive Food Lab. Detroit, Michigan.

Performing Microbiology tasks such as, Samples, Growing different types of Cultures, Gram Staining, Electronic Microscope, Culture Media Preparation, Autoclaving, & Sterilizing and performing Immunoassays “ELISA Tests”

1988: Red Cross Volunteer, Detroit Red Cross Drive, Detroit, Michigan

Handling Blood and Blood Withdrawing.

1987: Hospital Volunteer, Southeast Detroit Hospital, Detroit, Michigan

Performed Blood Banking, and medical lab technician‘s tasks.

AREAS OF EXPERTISE

Tri-lingual (Arabic, Aramaic, and English) LC/MS/MS HPLC Micromass 2790, 2690 Sciax API-3000 & 4000 ELISA & Rapid Test Protein Binding Quality Control DNA Sequencing &DNA Double & Partial Digests (PCR) PCR, Southern & Western Blotting SDS-PAGE Microbiology Analytical Chemistry PC Use, Windows, Microsoft Word, Excel, Access, Power Point, and Office Publisher Documentation and Data Management Report Writing

EDUCATION

1998 Bachelor of Science in Biology, SDSU, San Diego, CA.

1989 Associate Degree in Medical Lab Technology, Highland Park College, Highland Park Michigan

PROFESSIONAL DEVELOPMENT

LC Resources, “The Practice of Modern HPLC”, Feb. 2001 ResTek, “Comprehensive HPLC Seminar” June 2002

Applied Biosystems, “Mass Spectrometry for Lead Identification and Optimization Seminar”, November 2002 Watson LIMS Version 7.0, August, 2003 Waters, Mass Spectrometry System: “Exploiting the Potential of LC/MS with Exact Mass Spectrometry for Metabonomics” Nov.2003

PROFESSIONAL AFFILIATIONS

Howard Hughes Biology Education Initiative at SDSU 1997-1998.

Highland Park Community College; Two years full paid scholarship of being on the Deans’ List.

REWARDS

I was rewarded many Certificates of Appreciation and Metal Coins for excellence in performance and professionalism. Also, I was awarded many recommendation letters As well. (Will provide upon request).

Active Final Secrete Clearance (Awarded on 11/17/2008)



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