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Hello, I am Daria Rotnov.

Result-driven and motivated professional with 12+ years of diverse technical background with experience in Quality Control, Quality Assurance, Product Development and Validation in the regulated life science industry.

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Over twelve years of experience!

ISO 9001

ISO 22716

ISO 17025

ISO 13485

FDA 21 CFR part 210

FDA 21 CFR part 211

GMP

Kaizen

Lean

6 Sigma

CE-IVD

FMEAs

FAT

SAP

EXCiPACT

EP/USP/BP/JP/ACS/FCC

5S

Fourth Shift

ETQ Reliance

STARLIMS

A little bit about me

College

I have had a longstanding interest in microbiology and virology, which led me to pursue a degree in the field. The journey was arduous, but the rewards were plentiful. My studies at the Department of Microbiology-Virology-Biochemistry at one of the world's oldest and largest universities equipped me with the tools necessary to learn and overcome obstacles. I graduated with a Bachelor's degree in Biology (microbiology) as well as engineer analysis.

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A picture of a 3 micropipettes.

Professional Activity

I began my career as a Senior Quality Control Lab Technician, where I was responsible for conducting chemical, physical, biological, and molecular analyses. I coordinated and maintained proficiency testings for ISO 17025 and assisted with ISO audits. Furthermore, I trained level 1 and level 2 technicians and worked within multiple Regulation systems and compendial methodologies. Additionally, I developed analytical test method validation protocols, created and maintained a keep stock program, and was a member of both the 5S team and an emergency response team. Due to my success in this role, I was promoted to the position of Developmental Manufacturing Specialist.

As a Developmental Manufacturing Specialist, I was responsible for creating, formulating, and revising manufacturing processes and methods. I manufactured pilot and experimental batches, established protocols for new products. Additionally, I prepared work instructions and Standard Operating Procedures (SOPs), trained manufacturing technicians, and was the primary responsible party for daily precision manufacturing and developmental laboratory support activities that were necessary to maintain operations.

From that I had the opportunity to expand my experience as a Quality Assurance Coordinator with a cosmetics manufacturer. I reviewed, revised and established controlled documents and conducted internal audits to ensure compliance with GMP standards.

Because of my success at my previous employer they recruited me as an Associate Validation Engineer. My exemplary work ethic and results led to my promotion to Senior Validation Engineer, in which I designed, executed, coordinated and supported validation activities at four sites across two states and two countries for new product launches, new equipment, and the validation of legacy equipment and products.

I can certainly elaborate and fill in the blanks if you’d like but this is a summary. For more information visit my LinkedIn

Certificate Project management Certificate Root cause analysis and the 8d corrective action Certificate Management skills for new and experienced managers Certificate computer system validation Certificate Risk management Certificate leadership skills

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