Management Data

Hindu PIDAMOI

email; ********@*****.***

CELL; 858-***-****

TECHNICAL Strong experience with Document control, Data

Management, Coordination, updating,

SUMMARY: document Archiving, control, Evaluating

requirements, data updates and requests, developing

Reports and analysis in support of

business activities

EXPERIENCE:

10/14 - 02/15 Genzyme, - Eliassen Group, Allston, MA

Document Control Coordinator

. Maintained EDMS Documentation, Engineering Turnover Package

(ETOP) documentation Trained modified and applied Standard

Operating Procedures (SOPs).

. Maintained Document Management processes for cGMP/GDP

documents

. Created templates for Updating, maintaining logs, databases

and an accurate tracking tool that is acceptable.

. Combined Suite 1 project, to track each CQV and related

document through its drafting, review and approval cycle,

. Edited documents with formatting and template requirements.

. Uploaded transmittals on Sharepoint under DPS, created the GZ

transmittal outgoing, and updated the DPS transmittal tracker

using excel.

. Updated the change control sheet

. Printed out the transmittal engineering drawings and

documents and then filed them.

. Archived and retrieved document records as needed to

responsible parties

. Interfaced with the 3rd party, to verify on doc priorities in

conjunction with project schedule.

. Called, and wrote to, tracked down approvers and "nicely"

forced them to sign.

. Prepared Purchase Requisitions (PRJs) for Purchase Orders

(PO's)

. Onboarding and off boarding new contractors

. Delivered and Monitored of contractor training

. Provided support to project managers and the executive

project coordinator to coordinate small projects

Utilized MS SharePoint, Word, PowerPoint, Excel and project to upload data

03/14 - 09/14 Cubist Pharmaceuticals, - Knf&T Staffing Resources,

Lexington, MA

Document Data Coordinator

. Entered Standard Operating Procedures (SOPs), Work

Instructions (WIs) and Quality Policies (QPs), data from the

Cubist GXP library into the Production instance Learning

Management System SharePoint and a Quality Management

database, in a cGMP regulated environment.

. Archived documentation, provided data entry coverage for

routine activities, and assisted with analysis as needed.

. Performed double entry of clinical data to ensure no data

entry errors exist.

. Created training documentation for Clinical Data Management

(CDMA), and Good Clinical Practice (GCP) trial staff, ensured

processes are consistently understood and implemented.

. Participated in internal process improvement initiatives

related to GCP compliance.

. Created and revised Standard Operating Procedures (SOPs),

Work Instructions (WIs) and Quality Polices (QPs) from the

Cubist University GXP Library into the Cubist Learning

Management System (LMS) SharePoint

. Created items in the Production instance Learning Management

System (LMS) SharePoint, edited items, created content,

managed content, created curriculum, edited curriculum,

attached links to the content from the GXP library

documentation, managed content, run reports, revised items,

reset PIN numbers for staff to access their trainings.

Utilized, Word, Access, excel and PowerPoint. Utilized Snag It screen

capture tool to create engaging visuals, edit, organize and share

technology Used for the projects. Utilized MS Visio to create diagrams that

communicated process information at a glance,

07/11 - 11/13 Patient Safe Solutions Inc., - East ridge Group, San

Diego, CA

Document Data Associate

. Managed Data Reporting and Systems Queue, executed testing

plans and ensured that data updates are made in a timely

manner in a cGMP regulated environment

. Automation of business processes. E.g. updating of data using

a GUI.

. Edited Standard Operating Procedures (SOPs), documents,

according to format and template requirements.

. Auto filling and renaming of files, downloading a specific

file name that saves itself to specific directory and changes

the name to a desirable one.

. Perfomed Standard Operating Procedure improvement, management

and compliance.

. Exported tracking product and client hospital data from the

CRM system into Ms Excel, utilized excel pivot tables,

Vlookups, linking spreadsheets, data automating and formulas.

. Utilized excel and Customer First solution database and

department resources for product knowledge, and documented

client transactions in the database.

. Entered data from technical assembly and repair document

records into a Quality management database. Fulfilled Data

requests using Structured Query Language (SQL).

. Extracted, transformed and loaded (ETL) data across many

different sources into excel to create consistent, accurate

information for QA testing of patient touch units as original

configurations requirements.

. Performed other responsibilities upon request, as needed,

with or without accommodation.

Utilized MS SharePoint, Snag It, MySQL, Visual Basic, Excel, PowerPoint and

Excel to manage data

EDUCATION:

06/06 Makerere University

. Bachelor of Science Quantitative Economics

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