Raw Materials Data Entry
Resume:
Belay Ayele
************@*****.***
Waltham, MA *2453
Summary:
● A focused and disciplined Laboratory Professional with more than nine years of lab experience.
● Experienced in Ordering, receiving of lab supplies and reagent. Creating database to track incoming Reagents and expired Reagents.
● Maintaining and reviewing raw materials files; routine equipment maintenance and calibration; ordering, receiving
of lab supplies and create database to track incoming chemicals and expired chemicals using Excel
● Maintaining online Gas monitoring testing online gas port using Gas Chromatograph
● Entered in house result and incoming sample to Excel
● Monitored chemical inventory database to track incoming reagents and expired reagents with Excel
Skills:
● GMP
● Batch Records
● Gowning
● Harvesting
● SOP
● Bioreactors (up to 3000 L)
● Monitored chemical inventory
● Perform buffer prep, media prep, including pH, titration, osmolality adjustment, sterile filtration techniques, and aliquots
● Setup and assembly of transfer carts/panels, SIP, media/buffer transfer
● Ordering lab Supplies, reviewing raw materials
● Creating database to track incoming Reagents and expired Reagents
Education & Certification:
● Kolfe Comprehensive High School, Addis Ababa Ethiopia
● Billing and Coding, Diploma, Graduated with Presidents list, Everest College Dallas, TX 2005-2006
oCourse Highlights: Medical Terminology, Anatomy & physiology, Reading and Coding Operative reports manually using ICD-9, ICD-9 procedure, CPT, and HCPCS Codes
oEntry of patient’s demographics for inpatient & outpatient (CMS-1500)
oUnderstand EOB’s for posting payments and adjustment
oBilling to carries such as Medicare, Medicaid, Blue Cross Blue Shield, Worker’s Compensation and
Commercial Carriers
oKnowledge of HIPPA & Commercial Carriers
oMicrosoft Word, Access, Excel, PowerPoint, Lotus, Nautilus, LIMS, Nugenesis, Mediware(Medisoft) and the Internet
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● Biomedical course, Graduated with Certificate, Bunker Hill Community College Boston, MA 1999-2000
oCourse Highlights: Inorganic Chemistry, Biochemistry, Organic Chemistry; Biology and Medical Terminology
oMedia Preparation; Laboratory Instrumentation (Balance, pH Meter, Centrifuge, Electrophoresis, and Spectrophotometer); Liquid Measurements (Pipets and Pipet Guns); Solution Making by Molarity, Normality and Percent
oCell Culture and Sterile Technique; ELISA Immunoassay; Protein Quantitation; Protein Purification by Column Chromatography; Bacterial Transformation
oCurrent Good Manufacturing Practices (cGMP), GXP and Quality Assurance, Batch records
● Quincy College, MA 1997-1998
oAcademic Program: Mathematics; English; Accounting I; Speech Communication and Computer class
Sanofi Genzyme Allston, MA Sep 2017 - Present
Manufacturing Tech II Harvest, Capture and Clarification Department (HCC)
● Operates general manufacturing equipment using Delta V Software under close supervision in accordance with current GMPs or standardized procedures and within safety guidelines
● Run Delta V system to make routine buffer and media preparation, filtration in 3000L Vessel
● Using Athena and ERP (Enterprise Resource Plan) software to track samples and supplies
● Perform Micro Filtration (MF) and CIP using Delta V system
● Perform loading Chromatograph and Elute/Storage/CIP using Delta V System
● Brings deviations in process protocols to supervisor attention.
● Maintains all associated documentation for operations being performed.
● Reviews and records physical inventory of stock items
● Receives general instructions on new work, which is generally reviewed upon completion
● Attend shift change over meeting
● Followed very strict GMP
● Batch records, buffer preparation
● Has experience working under gowning conditions
Thermo Fisher Scientific Inc., Cambridge, MA Dec 2016 - Jul 2017
Sr. Site Specialist SUL
● Responsible for cross site record retention and archiving for all assets Perform complex calculations based on Molarity, percent by volume, dilutions, ppm and ppb.
● Prepared high quality specialize solutions, including buffers, reagents, and cell culture media
● Performed media prep, including pH, titration, osmolality adjustment, sterile filtration techniques, and aliquots
● Responsible for inoculation small flask (out of freeze and thaw), 500L Bioreactor, wave bag
● Performed split cell culture operations in hood, including sampling, passaging, and vial thaws
● Performed Calibration, equipment verification following manufacturers protocols
● Monitored cell growth, run Blood Gas Analyzer instrument, Nova CDV instrument, Nova Flex, Nova 400, BioHT, Osmo
and Centrifuge instrument to calculate PCV result
● Has been responsible for verification of peer calculation, technical documentation, equipment log books and approval of completed documents and entering result in LIMS or e-Run Sheet system.
● Performed HTST and CIP operations
● Setup and assembly of transfer carts/panels, SIP, media/buffer transfer
● Using Computerized Maintenance Management System (CMMS) to track lab equipment information including calibration schedules, open work orders
● Using autoclaves for sterilization of bioreactors and related materials
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● Run DeltaV system to monitor 100L, 200L and 500L Bio reactor
● Run --- to use100L, 200L, 500L and 2000L mix vessel to prepare large quantities of media
● Working under GLP, GMP, cGMP and GxP
● Initiated and document minor deviations
● Supported change over activities
● Adhered to safety requirements
● Embraces Practical Process Improvement (PPI) methodologies
● Responsible to monitor metric data for work performed
● Followed strict GMP
OASys Water, Inc. Boston, MA Aug 2015 - Aug 2016
Laboratory Technician
● Responsible for reverse osmosis (RO) and forward osmosis (FO) membrane characterization testing
● Independently executed membrane testing following established standard operating procedures (SOPs) for both quality control (QC) and material development
● Responsible for inspection, troubleshooting, and regular maintenance of bench-level test systems
● Prepared solutions to achieve target concentrations
● Responsible for visual inspection of membrane coupons and reporting of any abnormalities
● Compiled and summarized testing results
● Entered in house result and incoming sample to Excel
● Collected, labeled, and submitted solution samples to the Analytical team and LIMS
● Monitored chemical inventory database to track incoming reagents and expired reagents with Excel
● Prepared presentations (using power point) and communicated results and trends to supervisor and peers in the Membrane Research & Development team
● Track lab equipment information including calibration schedule and open work orders by using Computerized Maintenance Management System (CMMS)
● Followed strict GMP
Boston Clinical Laboratories, Inc. Waltham, MA Mar 2007 - Aug 2015
Laboratory Technician
● Process patient data entry information into the computer (LIMS) for laboratory testing and billing
● Prepared chemical solutions, reagents, and specimens for chemistry testing; performed laboratory tests; analyzed and reported findings; investigated atypical results and discrepancies to determine causation
● Responsible for cytology, Chlamydia and endocrine specimens testing
● Prepared thin prep slides on the Cytic (Thin prep 2000) instrument under the supervision of the medical technologist
● Responsible for stain cytology slides
● Responsible for Centaur Immunoassay instrument for testing Chemistry Samples. Performed DCP, WCP & MCP
● Responsible for Olympus AU640e instrument for toxicology test. Performed DCP, WCP & MCP
● Responsible for Immulite 2000 instrument for Immunoassay test (Homocysteine, insulin, H. Pylori, IgG, FT3, FT4, T3, T4, and Thyroglobulin). Also, performed DCP, WCP and MCP
● Ordering, receiving of lab supplies and reagent. Create database to track incoming Reagents and expired Reagents
● Prepared presentations (using power point) and communicated results and trends to supervisor and peers in the lab department team
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Biogen Idec Inc. Cambridge, MA May 2000 – April 2005
Sr. Lab Tech I, Quality Control (QC-CHM) department
● Raw material testing; in-process, finished product, and stability product testing using pH meter, conductivity, Osmo, UV-Vis Spectrophotometer, GC, TOC and Flow Meter
● Sending raw material samples to contract lab; create database to track in house testing and outside testing raw materials
● Maintaining and reviewing raw materials files; routine equipment maintenance and calibration; ordering, receiving of lab supplies and create database to track incoming chemicals and expired chemicals using Excel
● Maintaining online Gas monitoring testing online gas port using Gas Chromatograph
● Login Raw Material Samples in Lab (using LIMS). Generate Business Object Report for Raw Materials
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