Quality Control Assurance
Resume:
Neha Jain
***********@*****.***
Edison, NJ 08837
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
Contact this candidate