Quality Assurance Technician

Lubov Arotsky 609-***-****

Voorhees, NJ ***** ********@*****.***

PROFESSIONAL EXPERIENCE:

Wuxi Apptec

Stability Coordinator June 2013 – Present

• Work in Conjunction with the Stability Coordinator in the initiation, running, and closing of all R&D and GMP stability studies

for a variety of biological products

• Author stability protocols, assess and compile results from the various laboratories in order to assemble data summary tables

and/or final reports for each stability study.

• Communicate with various Project Managers and clients on details of each stability study and support documentation that is

used for client filings.

• Perform responsibilities captured below (Associate Laboratory Technician)

Associate Laboratory Technician/QC Analytical April 2011 –June 2013

• Perform assays according to and in compliance with GLP, cGMP, CFR, and PTC guidelines and SOPs

• Organize and support testing for various samples including drug product, patient immunogenicity samples, pharmacokinetic,

and manufacturing intermediates.

• Collaborate with project management to prioritize and organize critical samples.

• Streamline daily performance for up to three assays at a time for various client testing at a time including ELISAs, IEFs, SDS-

Page, western blots, horizontal gels, pH testing, Osmo testing, TOC, CE, CIEF, and UV-Vis; majority of said assays performed

in vitro on large molecules such as proteins and immunoglobulins.

• Evaluate pharmacokinetic and other patient samples through various ELISAs

• Ability to perform cell culture, especially for use in cell based potency assays

• Assist in the development and validation of analytical methods by performing various assays such as ELISAs and western blots

and providing feedback as to what the next step should be in the developmental/validation process.

• Process the analysis of testing performed using software applicable to each piece of equipment:SoftMaxPro, MaxScan, and

Image Quant TL; western blot analysis also performed by ECL Detection.

• Reporting of results to clients by writing Certificate of Analysis and/or Final Reports using M.S. Word and M.S. Excel.

• Cross-trained to conduct the Quality Assurance review of batch records, final reports, and raw data for none Quality Control

assays performed in and out of the facility.

• Assist in the training process of new members to the department by creating training modules and leading side by side training

for various analytical assays.

• Support client audits and regulatory inspections such as the FDA, TGA, and others

Advanced Biomedical Laboratories

Clinical Research Laboratory Technician October 2010 – April 2011

• Receive various laboratory samples, log them into computer data base, and properly store along with freezer maintenance.

• Maintain logs for various laboratory protocols in adherence to CLIA regulations. Describe and interpret results of analysis in

written reports using Microsoft Word and Microsoft Excel.

• Creating and working off of Standard Operating Procedures.

• Interacting with various clients to coordinate sample shipments and sample testing by e-mail, phone calls, and weekly meetings.

• RNA and DNA extraction using EZ1 BioRobot.

• Performing ELISAs and PCR on extracted DNA and RNA.

• Various laboratory routines such as aliquotting samples, reagent prep, autoclaving various waste products, and maintenance of

various instrumentation

EDUCATION:

B.S., Biochemistry, Rowan University, Glassboro, NJ September 2006- August 2011

Contact this candidate