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.





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.


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