Clark Schultz Email & Phone Number

Edgar, Ne, Us

Fairmont, Nebraska, United States

Fairmont, Nebraska

Fairmont, Nebraska

• Working understanding of ISO and FDA regulations• Provided daily guidance and leadership to quality team• Managed day to day activities to ensure all product milestones were met in accordance with established schedules and standards• Developed, maintained, and utilized appropriate data analysis tools to evaluate and predict product performance attributes• Generated CoA(s), CoC(s), Assays and any other required product documentation.• Approved and released conforming product. • Documented non-conforming product, quarantined non-conforming product, and cooperatively assisted with resolution efforts• Documented non-conforming product, filled out appropriate non-conforming documentation, variances/deviations, CAPAs, scrap tickets, inventory transfers, and represented the Quality Control department in all follow up meetings • Trained new Product Specialists, functioned as a mentor and knowledge resource to new and/or assigned Product Specialists• Authored, reviewed, and approved new and revised documentation/protocols utilizing Reliance

• Working understanding of cGMPs and SOPs• Accurate documentation of procedures performed according to cGMP• Utilized laboratory instrumentation such as LCs, GCs, and TOCs• Transfer of data utilizing LIMs system integrated with Empower• Utilized laboratory techniques according to USP/NF/EP• Trained on DEA and FDA regulations for handling of raw material products

• Assisted in laboratory research with lipid membranes extracting phospholipids for LC analysis• Worked on developing an isocratic solvent system to separate phospholipids using a polarized silica column• Operated and maintained LC instrumentation• Recorded laboratory procedures precisely to insure ability to replicate experiments in the future• Compiled data and consulted supervisor on research findings and implications