Meghan Christina Bono

Home Address

*** ********** ** **********, **

215-***-****

Email: adxus0@r.postjobfree.com

Objective

To obtain a position that will enable me to use strong organizational skills, educational background, and ability to work and lead well in a team atmosphere

Education

Temple University, Philadelphia, PA 08/2003-08/2008

Major: Chemistry

Degree: B.A. Chemistry

Work Experience

Merck & Co, West Point, PA

Position: Senior Specialist, Quality 09/2020-Present

Collaborates Globally on meetings as a Site Process Steward for GCM Trackwise

Business CoP lead of our area in IPI Implementation

Maintains the WPQO Change Control Unit Mailbox

Reviews submissions for Quality and initiates SQL *LIMS and GLIMS Change control requests (Vaccine, Pharm, Stability, EM)

Reviews submissions for Quality and initiates LIMS Change Control requests

Verification in GCM Trackwise, and second signature on LIMS applications

Implements GLIMS change controls, also maintains 3LIMs, when on call

Collaborates across sites interacting all IPTs at West Point, Durham, and Globally for GLIMS

Lead Change Analyst on the GLIMS for implementation in Global Vaccines and Biologics (Stability GLIMS project, Phase 1 and Phase 2)

Lead Change Assessment Tier for GLIMS changes

Reviews and author Standard Operating procedures

Merck & Co, West Point, PA

Position: Specialist, Quality Assurance 02/2018-09/2020

Maintains the WPQO Change Control Unit Mailbox

Reviews submissions for Quality and initiates SQL *LIMS and GLIMS Change control requests (Vaccine, Pharm, Stability, EM)

Reviews submissions for Quality and initiates GLIMS Change Control requests

Assisted LIMS team on special WIN 10 project -Performed test runs on Excel Workbooks, EM personnel verification in GCM Trackwise, and second signature on LIMS applications

Collaborates across the West Point site interacting with multiple Change Review Boards for process changes including PnP Expansion, Barrier, Sterile Supply, SPS, D&L, Site

Lead Change Analyst on the GLIMS project for implementation at the West Point Site

Pre and Post approve ECOs for the supporting areas across site

Past member that leads the Analytical Change Request Change Review Board and maintains the WP CRA Advisory Council mailbox

Merck & Co -via On Board, USA, West Point, PA

Position: Stability Analyst-LIMS 07/2017-02/2018

Created, maintained, and executed Environmental Monitoring LIMS (Pre-Approval) and Product Change Controls in Trackwise

Execute updates in SQL *LIMS as per Change control requests

Created and edited user Accounts in SQL*LIMS (Maintain all incoming user applications for SQL*LIMS)

Performed test runs on Excel Workbooks

Teva Pharmaceuticals, Horsham, PA

Position: Quality Analyst 04/2015-07/2017

Created, maintained, reviewed, and approved document Specifications in Laboratory Information Management System (LIMS)

Edited, Reviewed, and made documents effective in Wisdom (Document Management System)

Ensure compliance of quality control documents by authoring change controls (Trackwise) while managing the lifecycle through the system

Determine testing requirements and write protocols accordingly for method transfer, method validation and USP verification testing

Teva Pharmaceuticals, Sellersville, PA 09/2011-04/2015

Position: Associate Scientist II

Performed all required testing to release batches of pharmaceutical drugs in a Quality Control atmosphere

Worked with the Metrology group in calibrating HPLC instruments

Completed and managed many small projects consisting of method transfers, method validations, and standard qualifications

Assisted and Executed writing/reviewing protocols, reports, and data packets

Lead chemist on Secondary Standard Qualification project

Maintained and authored protocols and reports for Secondary Standard Qualification project

Assisted on inventory of controlled substances that came in and out of the laboratory, while working in compliance with the DEA representatives

Merck & Co, West Point, PA 09/2010-09/2011

Position: Biotechnician

Responsible for executing the functions required to produce the varicella vaccine on virus side in an aseptic environment

Performs work duties using automated systems (Delta V, BOI, LIMS) or manual operations in compliance with safe operating procedures, company and government regulations, and good manufacturing practices.

Cleans, assembles, operates, disassembles, maintains, trouble shoots and initiates corrective actions as necessary to meet production schedules

URL Pharma, Philadelphia, PA 09/2008-09/2010

Position: Quality Control Chemist/Analytical

Perform all testing for the release of lots/batches of pharmaceutical drugs in the

Quality Control-Finished Product and Stability departments

Analyze, record, and maintain reproducible data, qualitative and quantitative,

according to cGMP guidelines, SOPs, and FDA regulations

Skills/Activities

Instruments: IR, UV, GC/MS, HPLC, NMR

Training in: UV-Vis, KF, Dissolution, GC

TLC, HPLC-Waters/Empower, Impurities/Degradations, Blend Uniformity

SQL* LIMS, Laboratory LIMS (GLIMS), Wisdom/Midas, MEDS, eVal (Kneat), Trackwise, IPI

Power Application, Microsoft Teams

Windows XP; Excel, Word, and PowerPoint

Labware 8 Administration 1 ; Labware 8 Basic Configuration

Contact this candidate