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Madhura Sagare

Burlington MA, US

Phone: xxx-xxx-xxxx

Email: xxx@xxxx.xxx



  • Looking For: Quality Control Associate, business analyst

  • Occupation: Life, Physical, and Social science

  • Degree: Master's Degree

  • Career Level: Fully Competent

  • Languages:

Career Information:

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Highlights:

Skills:cGMP, chemistry, hplc, Data entry


Experiences:

Quality Control Chemist II 08/2019 - 02/2020
Abbvie Bioresearch Center, worcester, MA United States
Industry: Pharmaceutical
QC Chemist
• Working knowledge of Raw Material Testing per USP, EP, and JP compendia. • Worked per the Thermofischer Sample Manager LIMS. • Worked on Thermofisher-TruScan to verify incoming raw materials and for the inspection of finished products. • Performed monthly water testing per USP compendia. • Carried out Gas testing of- O2,N2,CO2 per USP, EP compendia. • Planned and executed assigned laboratory tasks utilizing standard procedures and technical understanding of various techniques to complete assigned tasks. • Regularly provided data reduction with some interpretation activities. • Developed protocols for more complex tests or experiments performed with less defined assays and parameters. • Applied basic computer skills including word processing, spreadsheets, and instrument related systems. • Presented conclusions of defined experiments. • Ensured safety and GxP requirements are met when performing tasks. • Ensured timely and GxP compliant delivery of high quality precise data.--
Senior Lab Technician 01/2013 - 12/2015
Roche Molecular Systems, Somerville, New Jersey United States
Industry: Pharmaceutical
Senior Lab Technician
• Tangential flow UF/DF: Diafiltration of oligonucleotide products using the Centrasette-P device. Operation of: • Incubators, pH Meters, Balances, Centrifuges, • Use analytical methods for the quantitation of small molecules. • Purified Oligonucleotides using Agilent, Varian HPLC having Waters EMPOWER software. • Fully document experimental methods and results • Handling important case reports in form of batch record. • Knowledge of GMP, ISO, and FDA regulations and audit • Experience with environmental monitoring, air and water sampling with GMP regulations. • Performed Cross Functional Lab audits for FDA Inspection. • Worked according to the approved validation protocols and reports together in compliance with the quality assurance and making the complete documentation (Batch Record) available for audit and inspection. • Reviewed chromatography data and provide preliminary data • Knowledge of chromatographic and analytical methodologies. • Maintained the facility, utilities, equipment and systems in accordance with the standard • Operated procedures, preventive maintenance and calibration programs. • Trained in working in the lab according to cGMPs, GLPs, SOPs and as per the Batch Manufacturing Documentation.--

Education:

University of Houston Clear Lake 08/2011 - 12/2012
Houston, Texas, United States
Degree: Master's Degree
Major:Biotechnology
MS in Molecular Biotechnology


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