Quality Maintenance
Resume:
Current Address:
Townsend, DE 19734
Ph. # 302-***-****
E-mail: **********@*****.***
Objective:
Seeking a challenging, responsible and rewarding Career in the field of Health Care, Pharmaceutical, or biotechnology where my education, knowledge, skills and experience could be properly utilized. It must also provide me opportunity to learn new tools, techniques and skills.
Summary:
• Bachelor of Science with majors in Chemistry, Physics, Botany and Zoology.
• Extensive experience in working with the Personal Care, Biotechnology and pharmaceutical companies with over 7 years.
• Experience in chromatography LC/UPLC/GC/MS Spectroscopy, Conducting Synthesis Organic reactions, NMR, IR, UV/AA, pH meter, Sonicator, Viscometer, Physical testing, Femcare string extractable testing ( raw and finish products ).
• Extensive experience and knowledge of Microsoft tools like Word, Excel, Internet explorer and Power point.
• Good understanding and knowledge of FDA GLP/GMP/EPA and 5s systems
• Good understanding and knowledge of System, application and Products (SAP)
• Completed Pharmacy Technician Course from University of Delaware.
• Successfully completed Certification in Data management and SAS from University of Delaware.
• Member of ASQ (American society of Quality
• Excellent verbal and written communication skill.
Education:
• Bachelor of Science (Chemistry, Physics, Botany and Zoology) - 1994, University of Rajasthan, Jaipur, India.
• Certification in Data management and SAS - University of Delaware
Trainings:
• Good Laboratory / Maintenance Practice (GLP/GMP)
• FDA Regulation & Preparation
• Environmental and Safety training
Professional Experience:
Energizer Personal Care, Delaware 10/2005- 5/2012
Quality Services, Senior Chemist
Energizer is a leading global consumer products company with various products pipeline in healthcare, skincare, infant care, and feminine care.
My responsibilities included conducting the multi-step synthetic organic reactions tests, setup of reactions apparatus, separations, purification and analysis by using approved methods and equipment’s like (LC, UPLC, GC, Mass Spectrometer, NMR, IR, UV, and Atomic Absorption).
Followed Standards, and guidelines (GLP/GMP) to ensure the safety and effectiveness of the company’s Quality products.
I am fully conversant and skilled in the following critical techniques, tools and tests needed to conduct the research and studies under compliances of standards and guidelines (GLP/GMP) to ensure the safety and effectiveness of the company’s Quality products.
My Responsibilities -
• Performed and reported results of analytical tests on active ingredients and organic compounds by using HPLC/UPLC/GC and Mass-spectrometer to support real time stability and manufacturing testing (both in-house and contract) Projects.
• Performed kinetics/Extractions test of Organic synthesis reaction of activated N-Nitrosamine (Melting point 118.C to123.C) with decomposition organic substrates.
• Performed the extractions on finish Products, Raw materials and organic synthesis compounds.
• Performed the Heavy materials analysis by using Flame and Furnace Atomic Absorption spectrophotometer.
• Performed Method transfers and Method validation for exciting and new research studies.
• Ensured completion of all laboratory investigations including documentation (Raw data and Lab Note Books).
• Ensured appropriate departmental personnel have been informed of work and testing status.
• Ensured laboratory equipment preventive maintenance, calibration and validation are completed on schedule.
• Documented and maintained the current calibrations and validations records.
• Trained and assisted others as needed in the validation and qualification of laboratory equipment and test methods SOP's.
• Updated Standard Operating Procedures to maintain compliance with corporate, federal and state guidelines.
• Responsible for training and mentoring of newly hired junior resources.
• Responsible to manage the Hazardous waste of laboratory under the compliance of OSHA regulation.
• Responsible to transfer and order chemicals.
• Responsible to Log and maintain Chemicals with their Current MSDS sheets and certificate of analysis.
• Implemented to 5s Lean for a pilot project.
Equipment’s/ Instruments: NMR, UV, FTIR, KFTitrino, PH, Organoleptic, Viscosity, Atomic Absorption, Extractions, Finish Products, GC, UPLC/LC/MS Instruments calibrations and validations.
Software: System application and Products (SAP), Agile, Access, share point Total Chrome Workstations Ver 6.3, Millennium Workstation, Water HPLC, MS Excel/ PowerPoint/Word
QPS, Delaware 02/2005- 09/2005
Associate Scientist / Lead Analyst
QPS is a leading bio-analytical company with big pharmaceutical companies like Pfizer, GlaxoSmithKline as clients. My responsibilities included designing and conducting Pharmaco-Kinetics and Drug discovery research, evaluate and analyze significance of scientific data and report the findings in compliance with Good Laboratory/ Maintenance Practice (GLP/GMP) requirements. I am also responsible for training/ guiding new lab personnel.
I am fully conversant/ skilled in the following critical techniques, tools and tasks needed to conduct the research/ studies
• Equipment’s Used: Balance, Pipettes, Centrifuge, Evaporator, Sonicator
• LC/MS/MS and Mass spec: Calibration, setup runs, generates, interpret the data according acceptance criteria, and analyze chromatograms.
• Pooled Blank Matrix (Plasma, Blood, Serum, Urine)
• Conducting extractions for drug studies.
• Development and update of Standard Operating Procedures for procedures and equipment.
• Operate the automatic sample preparation and liquid handling system e.g. Tomtec
• Method development for validation and sample analysis of analytical methods used to quantify drugs and/ or their metabolites in biological matrices and the description of assay ranges.
• Development and validation of novel immunoassays, enzyme assays, and cell-based assays LC/MS/MS assay Client sample assays to support drug analyte discovery and development
EDS, Delaware 12/2004 – 02/2005
Pharmacy Coordinator
Delaware Health and Social Services outsourced the pharmacy calls coordination needs to EDS. I am working on managing and coordinating the calls from Pharmacies, doctors and patients. The task involved great skills in understanding the needs of patients and doctors and coordinate with pharmacies to the resolution of issues to the clients’ best satisfaction. Used computerized systems to keep track of the calls and resolution records.
ASDI Biosciences, Delaware 01/2004 - 11/2004
ASDI Bio Sciences is a company dedicated to the analysis, measurement and supply of high quality chemicals used by pharmaceutical companies in the world. Their major clients are Pfizer, GlaxoSmithKline, and other major pharmaceutical companies. I was responsible for chemical analysis of the compounds, verification of the measurements and industry compliant packaging of the compounds so the integrity of the compounds is not compromised in transit. I was also responsible from time to time to guide a team of lab support team.
References:
References available upon request.
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