Professional Experience Quality Assurance

Charu Patel

Cell# 732-***-**** ** Creastview Dr.

***********@*****.*** Kendall Park, NJ-08824

OBJECTIVE :

To obtain a challenging position in analytical laboratory, which allow me to apply my experience, skill and knowledge of analytical chemistry.

Summary of Qualifications:

9+ years of progressive experience in analytical chemistry, method validation and ANDA stability, Commercial Stability, Raw material tests for Qualification of In-house Standards.

3 years experience in Microbiology field.

2 years experience in Industrial and commercial Waste water, solids and semisolid wastes analysis.

Experience with analytical techniques including HPLC, UPLC, Dissolution, UV/VIS and IR.

Experience in Calibration of HPLC, UPLC (i.e. Calibration of Detector, pump, auto-injector, Column Heater), Dissolution Baths, Disintegration Apparatus etc.

Strong problem solving and trouble shooting skills.

Outstanding written and verbal communication skills.

Strong investigation writing skill using Track Wise Program.

9 years strong experience and knowledge of doing analysis using Electronics Notebook program.

PROFESSIONAL EXPERIENCE

OHM Laboratories, a Sun Pharma Company, New Brunswick, NJ

QC Chemist - From 2007 – Present

Performing potency Assays, Blend Uniformity, Content Uniformity and Related Compounds, Physical Testing, Dissolution, on In-Process powder, Final mix, Finished Products, Method Validation and ANDA Stability.

Excellent knowledge of instruments like, HPLC (Waters, Agilent and Shimadzu), UPLC, operation of dissolution baths with Auto-sampler, UV Spectrophotometer, Fluorometer, KF Titrator, Particle size and Tapped density Instruments.

Excellent experience of performing Dissolution profile, Assay, Content Uniformity with two or more actives.

Wide and excellent (9+years) knowledge of analysis using Electronics Note-book including understanding of creating analytical methods for analysis using Electronics Note-book.

Following SOPs and FDA regulations, and working in an excellent cGMP and GLP regulated and safe analytical environment.

Trouble shooting HPLC

Knowledge of performing investigations using Track Wise System and Knowledge of using DCM.

Bayer Inc/ Medsep Corp. (Pall Corporation), Covina CA

Quality Assurance Biologist – Jun 1993- July 1996

Environmental Monitoring: Which includes collection of surface swab samples from different critical parts of production area and instruments for clinical validation and test for microbial growth. Performing Air Microbiology in different parts of the production area for microbial growth.

Seeding: Make A. niger organisms inoculated samples ready for Autoclave load to put on critical points for sterility study.

Sterility Test: Testing of all samples come from Heat treater loads put for sterility and bacteriology study and plate reading for sterility and bacteriology study.

LAL testing of WFI, Pyrogen testing LAL, Final product LAL, Raw material LAL, Fiber shredding monitoring testing, Micro services, C. S. counts, weekly C. S. counts and A. niger control counts, Heat treaters Dose setting Audit testing.

Product validation project testing, test result reading, Test result reading, Tissue culture, Ambient and product mix testing, DE Ambient testing.

Paper work for documentation, making packets ready for product release. Good GMP practice and safety training programs, Attended Zero defect quality training program. Revising and updating existing Standard test procedures.

Chemical Consultants, City of Industry, CA

Laboratory Technician – Jun 1991- Jun 1993

Drinking water and waste water analysis, organic and inorganic solid and semi-solid wastes analysis.

Analytical testing like colorimetric, Titrimetric, gravimetric, extractions for organic and inorganic solids and Semi-solids analysis. Other normal tests like TOD, BOD and checking pH for solid and semi-solid wastes, Sample extractions for GC Analysis.

Samples logging in and reporting.

EDUCATION:

Bachelor of Science in Microbiology

S. P. University, India

Diploma of Medical Technology

Bombay School of Medical Technology, India

OTHER SKILLS/INTEREST

Lab Skills: HPLC, UPLC, Dissolution, Disintegration, TLC, FTIR, KF, UV/VIS.

Software skills: Windows XP,MS Office (Word, Excel and Power Point)

HPLC Software: Empower 3

Languages: English, Hindi and Gujarati

Other skills: Track Wise, DCM, Velquest (Electronics Note Book)

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