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Technician Quality Control

Location:
Shrewsbury, Massachusetts, 01545, United States
Posted:
January 17, 2019

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Resume:

LARISA M. KUBIT

*** ***** ******

SHREWSBURY, MA 01545

Home: ***/***-****

E-mail: ac78aa@r.postjobfree.com

Career Profile: Detail-oriented, highly motivated, experienced candidate with a strong analytical chemistry background looking for a Quality Control/Quality Assurance Associate, Research Assistant, Quality Control Analyst or similar position on a project team. The candidate has experience with analytical instrumentation including chromatography HPLC, UV-Vis, FTIR, MS, ELISA, LC/MS as well as viscometer and moisture analyzer for qualitative and quantitative analysis of carbohydrate products and proteins. Possess solid documentation skills and familiarity with GMP, GLP, SOP, LIMS, Trackwise, Empower, Chemstation, Smart Lab, Maximo and Analyst. Candidate has a BS degree in Chemistry plus 12 years’ experience in the biochemistry field. An enthusiastic, energetic individual with a strong work ethic and excellent attendance record who works well independently or as part of a team.

Employment: Charles River Labs Inc., Shrewsbury, Massachusetts

Formulation Technician II

March 2016- February 2017

Performs preparation of test article/substance dosage solutions/suspensions.

Pack, inventory and organize return test materials and analytical samples to

Sponsor. Assist in preparing responses to both internal and external quality.

Ensure raw data records are accurate, complete, and in appropriate order, and

meet protocol specifications and/or GLP requirements. Review documentation

of functions performed as part of quality control Requirements. Contribute to

Department operations improvement in areas such as SOP revisions, department

Inspections, and equipment maintenance.

Research Associate II

April 2017- October, 2018

Adhere to sterile practices for handling immunocompromised animals.

Perform subcutaneous tumor cell implantation. Accurately measure tumor

Volume. Perform Protein Extraction, Solid Phase Extraction and LC/MS testing.

Administer Test material via various routes. Provide quality care and

health monitoring for all animals. Collect and process biological samples. Ensure

That raw data records are accurate, complete and in appropriate order, meets

Protocol & SOP specifications. Input and review electronic data entries. Serve as

Lead/ primary technician for studies of standard complexity, including

Preparation of study specific forms. Follow Company SOPs, Policies, Practices.

Bristol - Myers Squibb Inc., Devens, Massachusetts

Quality Control Analyst, contract

January 2015 – April 2015

Performs routine testing and data review of raw materials samples and, in-

Process, batch release and stability samples of Bulk Drug Substance in a cGMP

Compliant environment. Performs routine assays such as UV-VIS Spectrometry,

SDS Page, Wet chemical analysis, utility testing (e.g. TOC, conductivity, and gas

Testing and more complex assays including various HPLC with Empower

Software methodologies (e.g.peptide map and carbohydrate analysis,) ELISAs,

qPCR bioassay. Experience with Trackwise, LIMS, Smart Lab and Powerpoint.

Barrday Inc., Millbury, Massachusetts

R&D Technician

February 2014 – December 2014

Operate complex instruments testing prepregs, resin and panels including

Mechanical testing such as Tensile, Flexure, Shear, Compression testing up to

5000 KGF, Climbing Drum Peel and Shrinkage Force. Physical testing includes:

Parallel Plate Reometry, Fourier Transform Infrared Spectroscopy (FTIR),

Nuclear Magnetic Resonance (NMR), Differential Scanning Calorimetry (DSC),

Thermo Gravimetric Analysis (TGA), cross-sectional digital microscopy,

Thermo Mechanical Analysis (TMA) and Dynamic Mechanical Analysis

(DMA).

Genzyme, Inc., Framingham, Massachusetts

Manufacturing/Quality Control Associate

January 2012 - July 2012

Operate complex systems and equipment in strict accordance with current

GMP's, SOP's, and safety guidelines. Initial job responsibilities include CIP of

Process equipment and purification/operation of Microfiltration and

Chromatography systems. Assist and/or lead the implementation of production

Procedures and equipment guidelines. Perform In-Process sample testing, Stability testing, Raw materials inspection, sampling, and testing, Revise SOPs, review documentations. Maintain cGMP of the lab (QC Chemistry and Raw Materials Lab) and follow the actions and rules of all compliance programs (i.e. log book entry and reviews, proper raw material and reagent disposal, temperature monitoring of equipment and QC daily laboratory maintenance log. Calibration of pH meter, conductivity meter, balance, etc. Managed laboratory purchasing, maintenance of equipment, and inventory. Knowledge of biological assays including, cell/tissue cultures, SDS-PAGE, western blot, ELISA and bioburdens. Created labels using LIMS System.

ThermoFisher Scientific Inc., Franklin, Massachusetts

Quality Control/Column Packing Technician

September 2008 - September 2011

Responsible for making different kinds of columns according to GMP and exceeded daily goals by 50% on average. Possess an understanding of process theory, equipment operation and working knowledge of manufacturing process following SOP’s. Tested columns on Agilent HPLC and performed troubleshooting of equipment as needed. Prepared test samples and buffers and ordered supplies. Maintain cGMP of the lab (QC Chemistry and Raw Materials Lab) and follow the actions and rules of all compliance programs (i.e. log book entry and reviews, proper raw material and reagent disposal, temperature monitoring of equipment, QC daily laboratory maintenance log. Calibration of pH meter, conductivity meter, balance, etc. Managed laboratory purchasing, maintenance of equipment, and inventory.

Vertex Pharmaceuticals Inc., Cambridge, Massachusetts

Quality Control/Senior Scientific Associate

February 2007 - July 2008

Responsible for peer reviewing and quality control checking data and

Documents generated within Formulation Department and entering results into

The database. Collected, processed and maintained excipient Certificates of

Analysis. Prepared organic solvent samples of active pharmaceutical ingredients

using Agilent HPLC. Weighed out solid compounds using balance for thermo

gravimetric analysis and differential scanning calorimetric analysis. Tested solid

Compounds using X-ray, nuclear magnetic resonance, microscope and hot plate.

Set up experiments using computer and analyzed results.

Verax Biomedical Inc., Worcester, Massachusetts

Manufacturing /Quality Control Technician

November 2005 - May 2006

Responsible for analytical testing, labeling and inspection of incoming and

outgoing products; managed the approval and release of manufactured materials;

Established, operated and maintained the Quality Control area and equipment.

Gained proficiency in the following techniques: HPLC, ELISA, UV and

Microbiological tests and immunoassay experience. Wrote SOPs and followed

GMPs for making saponin extract and analytical tests on animal bleeds.

Calibration of pH meter, conductivity meter, balance, UV spectrophotometer,

FTIR.

The Gillette Company, Needham, Massachusetts

Research Associate

January 2005 - October 2005

Responsible for routine laboratory work including analytical chemistry, rheology, Karl Fisher titration and compounding according to SOPs and GMPs. Conscientious, hard working and detail-oriented employee known for producing quality work with consistent results. Gained experience using UV, FTIR and Waters Millenium HPLC. Calibration of laboratory instruments as pH meter, UV spectrophotometer, FTIR and balance.

Alpha Analytical, Inc., Westborough, Massachusetts

Inorganic Chemist

October 2003 - April 2004

Responsible for instrument calibration and conducting inorganic analysis on soil, water and wastewater samples including TOC, pH and solids analysis according to SOPs and GMPs. Water testings (conductivity, Heavy metals, nitrates), solution and reagent preparation under hood.

Operated computerized test equipment and utilized electronic schematics to

Troubleshoot, ensuring compliance with specifications and verifying product

Integrity.

Biosource International, QCB Division, Hopkinton, Massachusetts

Data Analyst Technician

August 2000 - August 2001

Responsible for the analysis of peptides, in-process and finished products and recording results. Analyzed peptides for compliance with specifications using SOPs and GMPs. Gained experience using Mass Spectrometry Voyager software and Gilson HPLC.

EDUCATION: UNIVERSITY OF MASSACHUSETTS, Amherst, Massachusetts, Chemistry Graduate Program Fall Semester

Courses Taken:

Theory of Analytical Processes & Advanced Inorganic Chemistry

SARATOV UNIVERSITY, Saratov, Russia

B.S. Chemistry

Completed a final research project on the influence of special types of porous diaphragms on electron diffusion rates between electrodes in alkaline batteries.

SARATOV ACADEMY OF ECONOMICS, Saratov, Russia

B.S. Economics/Business Management

Skills: Microsoft Office including Word and Excel



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