Professional Experience Customer Service

Nataliya Morozova

Telephone: 201-***-**** • Email: *******@*****.***

Summary

Chemist with professional experience in analytical work under GMP/GLP requirements and

adherence to Federal and ISO regulations.

Worked in areas of Research & Development, New Business Development, Quality Control and

Assurance.

Demonstrated leadership in project management for method development and validation, test

method transfer, product formula improvement and new product formulation, product stability

investigations, competitive products benchmarking.

Experience with testing according to USP/NF, EP, ISO and established SOPs utilizing

instrumental, wet chemistry and physical testing techniques (HPLC/UPLC, Spectrophotometry,

Enzyme activity degradation, Viscometry, Titration - potentiometric and ion-selective electrode,

Conductivity, pH, Refractometry, Specific Gravity, Detail Reproduction,

Strain-in-Compression, Shore Hardness).

Computer skills:

MS Office (Word, Excel, Outlook, PowerPoint, Solomon); HPLC - Waters Empower 2 and 3,

PeakNet, Shimadzu; TrackWise (complaints/CAPAs); patent search.

Professional experience

11/2014 - 05/2017: Sonar Products, Inc., Carlstadt, NJ

● Developed new and validated new and existed HPLC methods for testing of Rx and OTC topical

Preparations - creams, lotions, ointments, otic drops

● Designed and executed method of HPLC test methods

● Performed product stability studies for new and established product formulas

● Investigated product complaints and OOS (out-of-specifications) events for root cause

● Prepared Validation Plans and Reports, Work Instructions and Stability Summaries

● Performed method transfer and optimization of HPLC methods to UPLC

4/1999 – 10/2014: Sultan Healthcare - Division of Dentsply International, New Jersey

● Set-up of in-house quality control for products by transferring, optimization and

validation of previously outsourced to contract lab HPLC analysis

● Interpreted and executed new test methods from reference sources (USP, EP, ISO

standards, contract lab test methods), wrote work instructions and trained other lab

personnel on methods and techniques

● Performed calibration, maintenance and troubleshooting of laboratory equipment,

prepared and standardized solutions, ordered and maintained laboratory supplies

● Designed and conducted stability studies by creating protocols and plans, testing samples,

analyzing test data and summarizing results to establish product shelf life and expiration

labeling

● Formulated new products in accordance with marketing strategic plans and conducted

technical leading of projects and design reviews within the framework of GIP (Global

Innovation Process) for new product development formulation process

● Prepared new product prototype samples and lab batches for evaluation by marketing

group or customers and for stability investigations; assisted in scaling up formulas for

manufacturing

● Provided technical support to Customer Service and Complaints departments on product

inquires and complaints

● Performed investigation of out-of-trend events in QC testing and methods transfer,

determined root cause of product non-conformances and developed corrective-preventive

action plans including improvement of existing product formulas or optimization of

batching procedures when necessary

● Assisted contract manufacturer (Caulk - Division of Dentsply International, Delaware)

with transfer of Sultan/Dentsply test methods; consulted on OOS, product

non-conformance or stability issues events; performed product evaluation when changing

raw material suppliers or adjusting batching procedures

● In collaboration with other departments within the organization worked on development

of Product Risk Management, Product Design History and Product Technical files,

MSDSs, DFUs, submissions for product foreign registration and EU Declarations of

Conformity. Participated in internal audits

Before 1999: Chemist, Ukraine

R&D Chemist - R&D Lab at Analytical Department of Chernovtsy (Ukraine) State University

Chemist - Certification Lab for imported foods, Chernovtsy (Ukraine)

Technologist - Circuit boards plant, Chernovtsy (Ukraine)

Education: MS in Chemistry. Chernovtsy State University, Ukraine

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