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Raw Materials Data Entry

Location:
Lowell, Massachusetts, United States
Posted:
April 26, 2018

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Resume:

Belay Ayele

ac49in@r.postjobfree.com

Waltham, MA *2453

781-***-****

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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