Kathleen Steigerwald, M.S. Email & Phone Number

Madison, Wisconsin, United States

Madison, Wisconsin, United States

Madison, Wisconsin, United States

Middleton, Wi

JOB DUTIES• Responsible for independently developing and validating HPLC MS/MS methods supporting FDA drug approval.• Performs the role of Principle investigator (PI) responsible for managing and overseeing projects from start to signed report in a timely manner, meeting client and business expectations.• Drafts and reviews complex reports, methods, and plans for each project. • Performs the role of PI and mentor for new and junior employees to guide them through the process and… Show more JOB DUTIES• Responsible for independently developing and validating HPLC MS/MS methods supporting FDA drug approval.• Performs the role of Principle investigator (PI) responsible for managing and overseeing projects from start to signed report in a timely manner, meeting client and business expectations.• Drafts and reviews complex reports, methods, and plans for each project. • Performs the role of PI and mentor for new and junior employees to guide them through the process and ensure they can PI projects in the future.• Helps as an in-lab resource for newer scientist.• Responsible for process improvement and 5S duties to make work flow easier and keep the lab safe and presentable.QUALIFICATIONS• Has many years of experience developing and validating small molecule assays using various techniques as well as experimenting and troubleshooting.• Collaborates well with multiple groups (QC, QA, Management, Analysts, Metrology, etc.) in order to present polished and finished work for clients.• Follows AAPS/FDA Crystal City Conference Guidelines, 21CFR320, 21CFR58, 21CFR11, GCP, GLP, SOPs, and 5S and has extensive knowledge of regulated environments and requirements of the FDA.• Knowledgeable of cGMP requirements.• Experience in teaching new Analysts how to develop and validate methods per guidelines as well as informing on how to use software and instrumentation.• Excellent ability to pay close attention to detail and keep thorough documentation for transparency and reproducibility.• Flexible to changing needs of the client or internal clients to best accommodate the customer.• Knowledgeable of Chemical and biological safety procedures. Show less

Middleton, Wi

Middleton, Wi

Middleton, Wi

Middleton, Wi

Madison, Wi

*Entered client data into departmental labware systems*Ensured samples had the correct testing, storage condition, and light sensitivity*Trained new employees*Participated in process improvement activities

Madison, Wisconsin Area

•Facilitated sales through answering questions and recommending products•Assisted in arranging and organizing merchandise•Worked cash register•Took inventory of merchandise

Madison, Wisconsin Area

•Supervised student workers by delegating responsibilities•Trained new employees on the cash register, sandwich bar and ice cream bar•Facilitated closing duties with respect to restocking and cleaning•Handled the safeguard of money at the end of the work day

Master’S Degree, Chemistry

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Bachelor’S Degree, Zoology

Activities and Societies: Novice Lightweight Crew, 2004-2005 Ronald McDonald House Charities of Madison, 2007-2009