Quality Control Training

Anitha Stanley

**, ****** **** ****, **********, MA - 01545

Phone: 508-***-**** (Home)

Email: **************@*****.***

Summary

Microbiologist with B.Sc. and seven years of work

experience in quality control looking to work in a

challenging environment with special expertise in USP &

EP Sterility Testing, Microbial Limit Testing, Bacterial

Endotoxin Testing, HIAC, TAC, and Bioburden Testing.

WORK EXPERIENCES

Genzyme : October 2011 to June 2012.

Quality Control Analyst.

. My responsibilities include EM monitoring.

AstraZeneca Pharmaceutical - 2003 to July 2011.

Microbiologist

. Working in a LEAN cGMP environment.

. Perform testing in FIFO (first in first out) to meet KPI requirements

using DDS board.

. Perform Sterility, BET, HIAC, Optical Microscopy, TAC, Bioburden,

Microbial Limit testing.

. Perform cleaning of incubators, refrigerators, freezers on a weekly

and monthly basis.

. Perform pipette verification on a monthly basis.

. Perform growth promotion testing of incoming media.

. Participate in annual re-validation of the isolator.

. Perform MRS2 (Microbiological Reporting System II) tasks such as

create/receive/read and verify EM plates.

. Collect waters and perform EM of the AstraZeneca Westborough facility

including the sterile core.

. Perform Nitrogen and Compressed Air monitoring and processing.

. Perform OQ and PQ of the Vitek 2 for Microbial Identification.

. Write Level 3 Deviations in Trackwise.

. Certified Train-the-Trainer, providing training to peers, senior

microbiologists and contract employees.

. FDA and MPA inspection preparation and readiness of the microbiology

lab.

. SHE team member for the Microbiology Department.

St.Agnes High School Bangalore, India - 1991 to 1994

Science Teacher

. Worked as Science Teacher, teaching Biology and Chemistry Curriculum to

students. Lab responsibilities include Dissection, mounting, slide

preparation and chemical tests.

TECHNICAL SKILLS

. Global LIMS/LIMS

. MRS2

. Endoscan-V for KTA

. PharmSpec for HIAC

. Trackwise for Deviations

. Plateau for SOP training

. MS word and Excel

Education

. Biotechnology course attended at Mass Bay Community College,

Wellesley, MA, USA in the year 2002.

. Bachelors Degree in Education (University of Bangalore 1989-1990)

. Bachelors Degree in Chemistry, Botany, Zoology (From the University of

Bangalore, India in the year 1987- 1989)

TRAINING/SEMINARS/CERTIFICATIONs

. Attended Hazardous Waste Disposal training and Aseptic Refresher

course.

. Attended The Parenteral Drug Association (PDA) on Pharmaceutical

Regulatory seminar.

. Certification in the Vitek 2 software and equipment operation training

by Biomerieux.

. Certification in Computer Fundamentals, MS Windows, Word, Excel.

. Certification in Visual Basics

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