Quality Control Technician

SUMMARY

Pharmaceutical professional who has extensive and dynamic experience in Current Good Manufacturing Practices (cGMP), Quality Control, compliance, training, auditing, curriculum development and data analysis. Detail-oriented team player who identifies curriculum improvements to meet independent geographic business needs across international organizations

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Flow Cytometry (Beckman Coulter FC500) CBC (AcT5 Hematology Analyzer) Viability Endotoxin ELISA Gram stain Manual Diff cGMP Method Trainer Fluorescence microscopy HPLC DNA, RNA and protein isolation techniques PAGE RT-PCR Northern, Western and Southern blotting Streak Plating Bioassay Microbial Identification Plaque Assay

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PROFESSIONAL EXPERIENCE

Dendron Corporation, Morris Plains, NJ (01/2010-Current)

Quality Control Associate

Performs routine and non-routine analysis of environmental monitoring program as well as in-process and finished products during release or stability testing by using various techniques(e.g. flow cytometry, ELISA, endotoxin, Gram Stain, complete blood count, viability)

Efficiently perform biochemical testing such as HPLC, pH, Conductivity, Visual Appearance on non-routine samples such as raw materials

Responsible for calibration and maintenance of laboratory equipment such as Flow cytometers, Plate Readers, Microscopes, BacT units, GE autosampler, Incubators and participated in Change Control process to ensure Compliance with cGMP, GXP, GLP and SOPs

Managed data within LIMS, worked in developing interface using chromatographic software such as WinKQCL, Gen 5 and MXP. Adheres to good documentation practices to ensure data integrity and traceability

Participate in internal audit program, including conducting audits of the QC laboratories, reviewing audit responses and follow-up to track resolution of all internal GMP audits and commitments

Analyzes data and writes up laboratory investigation reports (LIRs, ERs) and trending reports

Worked on Corrective Action/ Preventative Action (CAPA) and Out Of Specifications (OOS)

Responsibilities include Internal data audits and developing standard operating procedure (SOPs) and test methods

Document and review product information, Audit on In-Process, FP data and generate lab batch sheets

Train other QC personnel in specific procedures and analytical techniques

Create and maintain a Master Equipment list and Inventory Log for QC and Manufacturing

Maintains and monthly reviews instrument and equipment logbooks

Acts as technical expert within a specific functional area

Working knowledge on cGMP/FDA regulated industry

International Center for Public Health, UMDNJ, Newark, NJ (2002-2006)

Research Associate, Microbiology and Molecular Genetics Department

Conducted routine laboratory testing such as PCR, Western Blotting, HPLC and Flow cytometry under microbiologist or biochemist’s supervision

Harvest cell cultures at optimum time, based on knowledge of cell cycle differences and culture conditions

Cultivated and isolated microbial organisms by performing various microbial techniques such as Gram stain, Replica Platting

Selected and prepared specimens and media for cell cultures, using aseptic technique and knowledge of medium components and cell requirements.

Responsible for media preparation and maintenance

Performed tetrad dissection method to analyze the recombination in yeast genotype. Stored the result and analyzed with the help of kaliedograph and chi-square technique

Alembic limited, India (2000-2001)

QC Technician

Performed an inspection and microbial testing of raw material and carry out microbial assays

Conduct environmental microbiological testing programs

Performed environmental monitoring of the manufacturing facility and present data to microbiologist for review on a routine basis

Provide assistance to management with instrument troubleshooting, Laboratory investigations and Exceptional reporting

Responsibilities included receiving QC and storage of purchased media and reagents

ADDITIONAL SKILLS

Microsoft Office Suite, SAS, Oracle 8.0, MS Access, HTML, Visual Basic, Molecular Modeling, GCG, Bio-Edit, Gene Doc, MATLAB (imaging), SYBYL (drug-drug interaction, docking), MAPLE (mathematical), Excellent Verbal and Written Communication skill, Strong team work and Organizational skill

EDUCATION

SHRP-UMDNJ, Newark, NJ, 2005

M.S. in Science (Major in Biomedical information and Biotechnology)

Indian Medical Association, Gujarat, India 2000

Medical lab technician

Gujarat University, Gujarat, India, 1999

B.S. in Science (Major in Microbiology and Biochemistry)

PUBLICATION

Genetics, 2008 July; 179(3): 1221–1235: Meiotic Recombination at the Ends of Chromosomes in Saccharomyces cerevisiae

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