Summary
Overview
Work History
Education
Skills
Accomplishments
Volunteer Work
Languages
Work Availability
Timeline
Manager
NAZHA EL KHOURY

NAZHA EL KHOURY

EASTON,PA

Summary

Analytical, detail-oriented professional with 17 years experience in the Contract Research Organization industry. Exceptionally organized and focused, demonstrating an aptitutde to balance and prioritize a daily routine of data review in a fast-paced environment. Highly interested in a job in clinical research and data quality.

Overview

17
17
years of professional experience

Work History

QC Specialist

Labcorp Drug Development
01.2018 - 01.2023
  • Implemented GLP training and electronic data edit training for all new hires in the Animal Operations department
  • Participated in CAPAs, Gemba Walks and other process improvements, leading to a marked decrease in deviations
  • Assisted Study Technicians in reviewing data and generating deviations
  • Prioritized and performed daily data review of at least 20 rodent and rabbit studies at a given time
  • Participated in periodic SOP and data form revisions.

Study Manager

Labcorp Drug Development
01.2014 - 01.2018
  • Was responsible for overseeing the conduct of method development, validation and analysis of samples in support of regulated pre-clinical and clinical bioanalytical sample analysis studies.
  • Prepared SEND datasets of Bioanalytical data.
  • Worked with up to five Sponsors at any given time.

Analyst

Labcorp Drug Development
01.2006 - 01.2014
  • Performed a variety of wet chemistry techniques using various biological matrices to validate bioanalytical methods and analyze test samples.
  • Utilized several different software platforms and worked under GLP guidelines.
  • Handled and analyzed thousands of human plasma PK/PD samples.

Education

B.S - Biological Sciences

Rutgers, The State University of New Jersey
New Brunswick, NJ
2006

Skills

  • Calibrate Equipment
  • Monthly Performance Metrics
  • Corrective Actions
  • Watson LIMS
  • Analyst Software
  • Word Processing
  • Quality Control
  • Tibco Spotfire Data Analytics Tool
  • Xybion Pristima Data Collection

Accomplishments

  • Was the first Analyst in the Bioanalysis Department to complete training in the Waters UPLC lab instrumentation with accuracy and efficiency.
  • Collaborated with a team of approximately 20 Analysts and Managers in the completion of a clinical sample analysis study 10 days earlier than the Sponsor’s target completion date, resulting in additional departmental revenue of approximately $100,000.
  • Acted as Bioanalytical Study Manager for a compound that was granted Orphan Drug status by the FDA.
  • Assisted in the implementation and daily monitoring of offline data loggers for monitoring laboratory refrigerator, freezer and room temperatures during an unexpected network shutdown.
  • Most recently contributed to a citation-free FDA audit of the facility.

Volunteer Work

2019 - 2021, Treasurer, St. Theresa Sodality, Our Lady of Lebanon Maronite Catholic Church, Easton, PA.

Was elected Treasurer by a unanimous vote.

Planned and promoted three successful fundraising events, including an outdoor rummage/mask sale, an annual tricky tray raffle and an annual golf outing event, generating collectively tens of thousands of dollars in contributions.

Languages

Arabic
Native or Bilingual

Work Availability

monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
swipe to browse

Timeline

QC Specialist

Labcorp Drug Development
01.2018 - 01.2023

Study Manager

Labcorp Drug Development
01.2014 - 01.2018

Analyst

Labcorp Drug Development
01.2006 - 01.2014

B.S - Biological Sciences

Rutgers, The State University of New Jersey
NAZHA EL KHOURY