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:
Highlights:
Skills:cGMP, chemistry, hplc, Data entry
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.--
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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