ARKA SEN

** ******** ***.

Norwood, MA *****

Cell: 781-***-****

Home: 781-***-****

Email: adimfj@r.postjobfree.com

U.S. Citizen

SUMMARY

Professional with experience in the Information Technology and Pharmaceutical industry

EDUCATION

Northeastern University, Boston, MA

Master of Public Health in Urban Health,

Graduated in 2011 with GPA: 3.46/4.00; Relevant Coursework: Biostatistics using STATA and Epidemiology

Boston University, Boston, MA

Master of Science in Journalism

Graduated in 2008 with GPA: 3.05/4.00

University of Massachusetts, Amherst, MA

Bachelor of Arts, Cum Laude, in Journalism with minor in Information Technology

Graduated 2006 with GPA: 3.3/4.0

ADDITIONAL COURSEWORK

Boston University School of Public Health, Boston, MA

Introduction to Statistical Computing

January 2014 – May 2014

Topics Covered: Reading in Datasets, Manipulating Variables, T-Tests, Non-Parametric Tests, ANOVA, Correlation, Simple, multiple, logistic regression

Middlesex Community College, Bedford, MA

Graduate Certificate in Technical Communication

September 2015 – May 2016

Courses: Writing and Managing Effective Information; Tools and Technologies for Technical Writers

Barnett Institute, Interactive Web Seminar

CRA and CRC Beginner Program

July 2018 – September 2018

Topics: Drug and Device development; FDA and ICH guidelines; the roles of CRA and CRC; the types of monitoring visits; the role of IRBs; Safety, Accountability, and Regulatory Compliance.

Northeastern University, Level Program, Online

Introduction to Data Analytics

November 2018- February 2019

Topics: Excel, SAS, Tableau, SQL

SKILLS

Statistical analysis using STATA and SAS

SharePoint

Document management systems (SAP, myCIMS, and GEODE+)

LIMS

Technical writing and editing

DITA and Docbook

Framemaker

Editing SOPs

Excel (including Pivot Tables and Data Analysis)

Batch Records

VeevaVault

Scientific literature searches and reviews

Statistica

In Design, Quark Express, Photoshop

Robohelp

Tableau

SQL

INDUSTRY EXPERIENCE

Takeda Pharmaceuticals, Cambridge, MA July 2019 – October 2020

Manufacturing Specialist II (contracted through Randstad)

Managed data throughout the different manufacturing lifecycles

Entered and verified information from batch records in Statistica and LIMS

Brammer Bio, a division of ThermoFisher Scientific Feb 2019 – June 2019

Document Control Writer (contracted through ClinLab)

Write Specifications for Raw Materials

Route documents through ETQ to have them become effective

Retrieve Certificates of Analysis, Animal Origin Statements, Safety Data Sheets, and other related documents

Sanofi Pasteur, Allston, MA / Canton, MA Aug 2018 – Jan 2019; Jun 2017-Mar 2018

Documentation Specialist II (contracted through eTeam)

Edited Documents

Sent documents to workflow for approval using GEODE+

GMP Coordinator (contracted through SOFT)

Updated Deviation and CAPA data on Sharepoint

Monitor change notifications using Share Point and discuss and close them in weekly meetings

Tufts Medical Center, Boston, MA (contacted through Kelly Services) April 2018 – June 2018

Clinical Research Assistant

Archived Patient Eye Test Scans

Infosys, Quincy, MA (contracted through Office Team) May 2015 – June 2017

Project Analyst

Routing and Coordination of Inbound laptops and IDs

Imaging Dell Laptops, Configuring Dell Laptops

Participated in the audit process taking Inventory of Broken Laptops

Biogen Idec, Cambridge, MA (contracted through Flex Force) Jun 2014 – Oct 2014

Associate I, QA Doc

Extraction and archival of high priority files dating back to 1996

Training Scientists on use of Document Management System

Blue Stream Laboratories / Hospira Worldwide Inc. / Infinata Inc (Contract) Aug 2012 – Jan 2014

QA Documentation Laboratory Assistant / Documentation Specialist / Data Entry Clerk

Edited Standard Operating Procedures (SOPs) and Validations

Data verification in a Document Management System (SAP)

Johnson & Johnson, contracted through Kelly Services Oct 2011–Dec 2011; Apr 2008–Aug 2009

Data Management Support Specialist, Clinical Affairs Department

Archived Trial Master Files and Clinical Records through Iron Mountain

Managed and created inventory for product in the stock room

Reviewed documents for quality prior to sending to a Contract Research Organization

Administrative Assistant, Quality Department

Managed calibration of laboratory instruments on schedule

Participated in Quality unit investigations and follow-up action plan

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