Esther has been with the leanRAQA Team since January 2020 and has been supporting activities for chemistry, biocompatibility, sterility, packaging, and stability/shelf life. She has been in the medical device/pharmaceutical industry for the past twenty years supporting manufacturing changes, material contact support for device and pharmaceutical applications, sterility assurance, and has developed analytical methods including supporting and conducting method validations for impurity analysis. She has been performing biocompatibility assessments for the past 10 years and has survived and thrived during the many changes to Standards and Regulations.
In her professional career prior to joining the leanRAQA Team, she has conducted biocompatibility and chemical/toxicological assessments, conducted short term stability testing for pharmaceutical drug products, developed potency and impurity methods for pharmaceutical drug products, and authored many SOPs, scientific protocols and reports, and risk assessments to qualify materials for their clinically relevant use. Esther’s strength is her technical experience and her motto “Compliance will catch up with Science” drives her to stay ahead of current regulatory trends. Esther is currently working on completing her Master’s Degree in Toxicology from the University of Michigan and loves to spend any free time with her family trying and testing new recipes.