Regulatory Affairs Specialist

• May 2023 - Present

Regulatory Affairs Specialist

• May 2021 - May 2023

• Provides testing and documentation services to internal and external customers to ensure product meets all applicable quality and safety standards.• Prepares documentation for finished goods such as ingredient statements, MSDS, allergen information, nutrition information, kosher certification, GMO, organic, etc.• Updates databases to make regulatory data available to all the departments of the company to facilitate their work.• Submits information to outside agencies as required by TTB, OTCO, KOF-K, etc Show less

Quality Control Technician

• Jul 2018 - May 2021

● Performed chemical and physical analysis of final goods and incoming raw materials.● Created inspection plan in SAP program, creates or edits customer spec/technical data sheet, and obtains reference samples. Communicates with R&D, Regulatory and Customer Service to gather required input and coordinates with Industrialization for final release. ● Review certificate of analysis created by SAP program to ensure customer requirements are met prior to shipping● Primary point of contact for production for decisions on final good conformance and determine corrective action on nonconformities ● Environmental monitoring program point person for my site by performing ATP and allergen sampling, testing, and corrective action of deviations. Aseptic sampling for environmental swabbing, pathogen swabbing, air plates, and water samples and provides guidance in corrections and retest plan.● Overseed daily quality audit report: collects findings, notifies appropriate personnel and reviews actions taken Show less

Research Intern

• May 2017 - Aug 2017

● Assisted in moonshine flavor development for new distillery ● Formulated and compounded portfolio sample flavors for animal feed according to the experimental plan ● Performed and documented sensory evaluations for research staff ● Prepared culture samples and ensured sample purity by maintaining clean lab practices ● Executed microscopic evaluation of culture samples ● Performed prescribed experiments and tests and analyzed results ● Assisted in moonshine flavor development for new distillery ● Formulated and compounded portfolio sample flavors for animal feed according to the experimental plan ● Performed and documented sensory evaluations for research staff ● Prepared culture samples and ensured sample purity by maintaining clean lab practices ● Executed microscopic evaluation of culture samples ● Performed prescribed experiments and tests and analyzed results