Experience

Pegasus Laboratories, Inc.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Validation Scientist

  • Jan 2020 - Present

  Manage multiple validation projects within the Technical Services Department using a hands on risk based and data focused approach to developing product processes from pilot scale through scale up to commercialization through the validation process. Developing the foundation for evaluating statistical process control and implementation of tools for monitoring in a continued process verification (CPV) system in accordance with current ICH and FDA guidance. Apply data based and risk assessment approach to problem solving for both validation and commercial operations to increase process knowledge and understanding of process variability in order to reduce defects. Maintain the Cleaning Validation system and proposed updates that would bring the system current with recent guidance from FDA as well as align with EU market for compliance. In addition to the above, continued to maintain the functions of the Validation Specialist position.

• Validation Specialist

  • Oct 2017 - Dec 2019

  Process and Cleaning validation work in the Technical Services department including support of operations for the manufacture and packaging of pharmaceutical products. Primary responsibilities include writing and executing process validation, cleaning validation, and equipment installation/operation qualification protocols, writing standard operating procedures for equipment, writing validation summary reports for all drug products as part of the APR process, and conducting and writing system investigations in accordance with cGMP and FDA guidance. In addition, responsible for coordinating with operations to execute process and cleaning validations and providing support for operations during system investigations.

• Quality Control Analytical Chemist I

  • Feb 2016 - Oct 2017

  GMP/GLP Laboratory work in the Quality Control department working on Finished Goods produced for pharmaceutical use. Primary responsibilities include the testing of manufactured products and samples in support of stability studies as well as maintenance and calibration of equipment used during testing to ensure compliance with FDA regulations and product quality. In addition, responsible for maintaining the Reference Standard system used by both Quality Control and Technical Services, reviewing and revising SOPs through proper change control process, and calculation spreadsheet validation.



Trinity DNA Solutions

• Forensic Biologist Trainee

  • Jan 2015 - Jan 2016

  Laboratory work involving forensic evidence screening for chemical indicators of bodily fluids for use in DNA extraction and analysis. Perform validation studies of new chemistry, equipment and software before implementation in casework. Write SOPs, protocols and methods for implementation of new chemistry, software and equipment in casework. Reporting of results from forensic DNA analysis of evidence. Maintaining Quality Assurance by leading the internal audit process and overseeing proper Quality Control procedures and records.

• Forensic Technologist

  • Feb 2014 - Jan 2015