Summary
Overview
Work History
Education
Skills
Timeline
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Denise Kurtz

Reading,21081011

Summary

Responsible Group Leader/Supervisor with years of experience in Quality Control testing for large Pharmaceutical and Bio/Pharmaceutical Companies. Knowledge of GMP's, GLP's, USP and EP requirements. Extensive experience in writing internal investigation to determine root cause and corrective actions.

Overview

35
35
years of professional experience

Work History

BioPharmaceutical Microbiology Group Leader

Eurofins Lancaster Laboratories
Lancaster, PA
04.2021 - Current
  • Group leader/Supervisor for Facilities Validation and Testing Group
  • Perform the scheduling of all laboratory testing.
  • Provide open communication and consultation to current and potential clients
  • Writing scopes and quotes for new clients
  • Writing of testing protocols and client Studies, including Final Summary Reports
  • Writing exception/investigation
  • Provide Management with current CapEx needs and test pricing changes as needed

Senior Microbiologist II

Eurofins Lancaster Laboratories
Lancaster, PA
06.2019 - 04.2021
  • On-site and Offsite environmental monitoring, including surface, viable and non-viable air, hydrocarbon and dew point of compressed gases
  • Bioburden testing of waters to meet USP and EP requirements, swabs testing, biological indicator enumerations, Disinfectant Efficacy Studies, culture maintenance
  • Trainer for new analyst
  • Writing exceptions/investigations
  • Perform procedure revisions

QC Microbiology Supervisor

SmithKline Beecham
King Of Prussia, PA
06.1995 - 07.2000
  • Supervised QC Microbiology laboratory
  • Scheduled all testing which included; Environmental Monitoring of the manufacturing area, bioburden testing on water, raw materials and finished product, Endotoxin testing of finished product, and microbial identification utilizing VITEK System
  • Approved final test results
  • Writing of investigations
  • Quality Assurance Department during FDA audits

Senior QC Microbiologist

Rhone-Poulenc Rorer Pharmaceuticals
Horsham, PA
09.1989 - 07.1995
  • Quality Control testing on OTC Pharmaceuticals/raw materials/Water
  • Aseptic collection of water samples
  • Environmental Monitoring of the manufacturing facility including viable surface and viable air samples
  • Trained new hires on SOP’s
  • Familiar with BSL-3 clean room requirements

Education

Bachelor of Science - Clinical Microbiology

West Chester University of Pennsylvania
West Chester, PA
06-1989

Skills

  • Staff Management
  • Employee Development
  • Performance monitoring
  • Verbal Communication
  • Technical Writing
  • Schedule Coordination
  • Customer Service

Timeline

BioPharmaceutical Microbiology Group Leader

Eurofins Lancaster Laboratories
04.2021 - Current

Senior Microbiologist II

Eurofins Lancaster Laboratories
06.2019 - 04.2021

QC Microbiology Supervisor

SmithKline Beecham
06.1995 - 07.2000

Senior QC Microbiologist

Rhone-Poulenc Rorer Pharmaceuticals
09.1989 - 07.1995

Bachelor of Science - Clinical Microbiology

West Chester University of Pennsylvania

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Denise Kurtz