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Samha Joshi 2016 resume
- 1. Samha Lacoul 31587 Burnham Way, Hayward, CA, 94544 samha.joshi12@gmail.com, 5102890379 Seeking position as: Laboratory Technician / Quality Control / Quality Assurance / Research Associate / Scientist TECHNICAL SKILLS • Hands on experience in Shimadzu HPLC • LC, GC and UV Spectrophotometer • Mammalian cell culture such CHO cell line, NIHt3 cell lines and SP20 cell lines • QC Analysis and inspection of testing materials under GMP and cGMP regulations • Hemotocytometer and Cycle Counting • Mammalian cells culture • Bioinformatics, Sapphire LIMS, Empower, Chromeleon • DNA Extraction/Isolation, ClustalW, FASTA, NCBI • Gel Electrophoresis ,SDS Page and Elissa Assays • SOP, Change Control Requests, CAPA investigations • Serial Dilution • Aseptic Technique and HAZMAT Certified • Operation, Maintenance and troubleshooting of Water, Dionex and Agilent HPLC instruments. • Hands on Experience on Immunoassay, PCR, Real Time PCR, Capping and NASA assay • Buffer and Reagent Formulations, Single Channel Pipettes and Multichannel Pipettes • DNA Extraction from cells, blood and samples, NGS sequencing • DNA Hybridization and Fluidics Station • GMP,SOP, FDA regulated environment ADDITIONAL SKILLS • Detail oriented with well-developed oral / written communication skill • Quality Control / Quality Assurance • Microsoft Word, Excel, PowerPoint (Microsoft Office) • Proficient Email, Internet, Search, Social Media • Excellent Documentation and Organizing • Interpersonal skills • Individual contributor as well as excellent team player • Friendly and Fast Learner EDUCATION Ohlone College (Fremont and Newark, CA) Certificate in Research Associate (August 2014 - In progress) San Jose State University (San Jose, CA) Bachelor in Science, Health Science (2006 - 2009) Major: Health Science, Minor: Child Development BioHealth College (San Jose, CA) Certificate in Biotechnology Technician & Bioinformatics (January 2008 - December 2009) San Jose City College (San Jose, CA) Completed my Associate Degree in Science (2004 – 2006)
- 2. PROFESSIONAL EXPERIENCE (4 years of industrial experiences) Bayer Healthcare, Berkeley, CA (November 30, 2015 to present) Quality Control Analyst (Contract) • Performed analytical testing to support the release, stability and in process testing samples, or final products and supports the release of materials for production or products for commercial use in GMP and FDA regulated environment. • Accurately followed relevant SOPs, performed all activities in accordance with cGMP requirements reported abnormalities. Initiated and completed laboratory discrepancies events on time. • Documented test results to ensure completeness and accuracy per cGMPs. • Demonstrated hands on knowledge of operating, maintaining, and troubleshooting skills for Water, Dionex and Agilent HPLC instruments as well as quality and regulatory requirements pertinent to quality control labs. Performed moderate to complex equipment troubleshooting. • Prepared Sodium Hydroxide, helium and DI water Mobile phase for HPLC instruments,0.1 M Tris, TMS, 10%Acetronitrile and 5% Methanol buffers using QC balances and ph meter • Initiated Change Control requests in client’s document management system and followed through until the completion of workflows. • Followed SOP for chromatography systems and software(Waters/Empower, Dionex/chromeleon and Agilent) • Performed HPLC and Entered data and reagent preparation into LIMS. Reviewed data in both LIMS and hard copy test records. • Supported routine testing and performed HPLC testing to determine protein concentration to ensure immediate and final products are released on time. • Supported in Control Charts and qualification reports and reviewed logbooks. • Assisted in Lab discrepancy and DR investigations • Assisted in 5s for lab management and maintained equipments for running assays Citragen Pharmaceutical Inc., Fremont, CA (August 5th , 2015 to November 30, 2015) Quality Assurance / Quality Control Chemist (Full time) • Performed analytical testing to support the release, stability and in process testing samples, or final products and supports the release of materials for production or products for commercial use. • Accurately followed relevant SOPs, performed all activities in accordance with cGMP • Wrote SOPS, protocols, and reports as needed in support of pharmaceutical development. • Hands-on laboratory experience in formulation development • Hands on experience in using Spectrophotometer (UV/Vis, fluorescence, Mass Spectrometry) • Gathered information necessary to support changes to existing methods according to procedures or instrument repair and re-qualification. • Business market analysis and product line operations • Managed and trained two employees in operating and trouble-shooting Waters HPLC. • Changed SEC columns into water 2897 HPLC instruments. Affymetrix. Inc, Santa Clara, CA (November, 2014 to June, 2015) Research Assistant (Contract) • Performed laboratory experiments to generate reproducible/reliable data • Performed supervised testing of components and process modifications of biochemical assay products and designs • Maintained and presented accurate records, concisely summarized and reported data • Conducted computer-based data analysis • Operated PCR instrument and used analysis to do NGS analysis • Trained team members and my manager on operation of Fluidic stations and DNA hybridization oven • Assisted in Microarray analysis and performed reagent testing • Designed, conducted, and summarized, interpreted results and based on it prepared summary reports • Participated in presentation using PowerPoint presentations my scientific observation to team members • Maintained and documented all maintenance /testing records by following GMP/GLP guidance • Worked independently and unsupervised to execute IVD assays in Bench oriented Laboratory setting. • Used Excel Spreadsheet, Word Process and PowerPoint presentations in meetings to execute Scientific Analysis to my team members
- 3. • Performed Small Scale harvest of mammalian cell culture of NITH3 cells and SP20 cells for one year • Performed biochemical assays and bacterial culture assays under Bio-safety level II hood using reagents • Agarose Gel Electrophoresis, DNA extraction and basic nucleic acid enzymology (restriction digests, PCR, in vitro transcription). Took Time off to start Family and Training for Biotech Certificate (Aug 2011 to Oct 2014) Genentech, South San Francisco, CA (May 2011- July 2011) Media Preparation Technician (Contract) • Cleaning and preparation of a wide variety of small parts, vessels, and filter assemblies for use by Manufacturing using applicable Standard Operating Procedures in accordance with cGMP guidelines • Maintenance of cell culture in T25 flasks and batch fermentation in serum bottles • Operated autoclaves, water systems, and automated washers, and automated CIP systems • Performed data entry into LIMS, Excel Spreadsheets and ensured department compliance with policies and procedures. • Performed routine equipment maintenance and housekeeping. • Maintained a safe and clean work environment • Performed work according to applicable Standard Operating Procedures, Test Procedures, Forms, Safety Guidelines, and current Good Manufacturing Practices. • Participated in a variety of projects designed to improve the safety, quality, customer service, and efficiency of the department. Wafergene Biosystems, Fremont, CA (January 2011- March 2011) Research Assistant (Contract) • Used Multichannel Pipettes to prepare 96 well and 384 well immunoassays using Gyro immunoassay plate kits for printing DNA chips. • Material receiving, inventory, purchasing, and documentation • Managed general laboratory supplies • Monitored laboratory De-ionized water pH level • Responsible for shipping and handling • Data Filing and documentation • Daily GLP/GMP instrument(s) calibration and logging • Prepared Wash buffer and reagents • Operated Array jet Machine for DNA chip printing • Used PCR machine for Visual QC of the DNA Chips • Measured and Calculated Viscosity and Surface Tension of the Samples. • Experienced and Familiar with Flow Cytometry, fluorescence microscopy and • Wrote procedures/specification sheets for Quality Control Inspection and performed SDS page, Elisa, Gel Filtration and bacterial and mammalian cell cultures • Familiar with illumine sequencing platforms and experience with next generation sequencing library preparation. BD Bioscience, San Jose, CA (May 2010- September 2010) Production Lab Technician (Contract) • Prepared buffers and laboratory reagents according to SOP. • Prepared labeling, operated and maintained production equipments • Weighed, measured, and checked materials to assure batches • Maintained inventory of chemicals, antibodies or supplies. • Performed cycle counting and MRP transactions • Used Graduating Cylinder to prepare reagents and used Batch Records • Established and maintained logs and databases of instrument failures and defects • Calibrated and tested pH instruments, Spectrometer and other laboratory instruments in the company References will be provided on request