Neha Jain

abz1ts@r.postjobfree.com

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

Edison, NJ 08837

732-***-****

OBJECTIVE

To obtain a challenging position where I can maximize my scientific,

writing, research and quality experience.

EDUCATION

Masters of Science in Pharmaceuticals Systems Management

New Jersey Institute of Technology, Newark, NJ

Expected Graduation: 05/2014; GPA: 3.8/4.0

Relevant Coursework: Project Management, Total Quality Management,

Validation and Regulatory Issues in the Pharmaceutical Industry and

Management of Engineering Research and Development

Bachelors of Science in Biotechnology

Rutgers University, School of Environment and Biological Sciences, New

Brunswick, NJ

Graduated: May 2010; GPA: 3.5/4.0

Relevant coursework: Process Biotechnology, Concepts and Issues in

Biotechnology, Molecular Genetics, Methods and Applications in Molecular

Biology, Plant Gene Transfer and Comparative Virology

Scholarships

NJIT Fellowship, 2013-2014

Two Ten Foundation Scholarship, 2007-2010

Women Rehabilitation Scholarship, Fall-2007

WORK EXPERIENCE

Biomedical Quality Control Technologist II, June 2010 - Present

Quality Control Department, International Technidyne Corporation (ITC),

Edison, NJ

. Perform process validation of new test methods for medical devices -

Juniors and Responses

. Perform biological testing as required for product validation and process

validation on existing products

. Perform testing of biological raw materials and finished goods per

relevant SOP; release acceptable product

. Maintain product testing database and perform relevant statistical

analyses and trending associated with QC data

. Perform QC record audits as required under standard QA procedures

. Write experimental protocols and technical reports for validating new

test methods

. Write Out-of-Specification reports (root cause analyses) for products

that failed to meet the specification criteria in laboratory testing.

. Create and review Engineering Change Orders and Standard Operating

Procedures (SOPs)

. Perform risk assessments and analysis in FMECA procedures

. Evaluate customer complaints, determine root cause and develop CAPAs.

. Perform review of clinical data and responsible for the release of

accurate data to R&D.

. As required, work with the Technical Services, Quality Assurance,

Manufacturing, Research and Development (R&D), Clinical Affairs and

Marketing to investigate and resolve non-conforming material and

performance issues.

Research Assistant, May - August 2009

Department of Biochemistry, UMDNJ, Piscataway, NJ

. Conducted plasmid extractions and cell transformation.

. Performed His-Tag purification of proteins.

. Conducted cross-linking techniques of proteins using glutaldehyde

treatment.

. Carried out Single Protein Production (SPP) techniques.

. Performed protein chromatography, stability and analytical techniques

. Maintained cell culture and prepared various media for bacterial growth.

. Performed PCR reactions and ran DNA gels and SDS page.

LABORATORY SKILLS

. Proficiency in FDA-GMP/QSR, GLP, GDP, ISO 9000 regulations and possess

strong knowledge of ICH guidelines.

. Proficiency in Instruments: Sysmex Hemostatis System, Co-oximeter,

Hematology Analyzer and Microscopes.

. Lab techniques including PCR, DNA sequencing, gel electrophoresis, SDS-

PAGE, restriction enzyme analysis, protein purification, ELISA, serial

dilution.

. Yeast & bacteria genetics including yeast transformation, yeast genomic

DNA prep, plasmid prep, E.coli transformation, cloning using competent

cells, PCR mutagenesis.

. Microbiology techniques including gram staining, colony isolation

technique, replica plating.

. Proficiency in aseptic techniques

COMPUTER & PERSONAL SKILLS

. Microsoft Office: Word, Power Point, Visio, Project and Excel

. JDE (Oracle Based), Trackwise and Statistical Software (Minitab)

. Enterprise Resource Planning (ERP) and Laboratory Information Management

Systems (LIMS)

. Knowledge of Six Sigma in quality improvement

. Strong communication, writing, analytical and teamwork skills

. Proficient in speaking and writing of English, and Hindi

ACTIVITIES

. Certification of participation in the cancer awareness sponsor program

. Certification of cognitive and skills evaluations in accordance with CPR

and AED

. Proficient in phlebotomy

REFERENCES

Available upon request

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