DORJANA LIKA
South Plainfield
Summary
GMP-trained Analytical Chemist with a Master’s degree in Chemistry and hands-on experience in pharmaceutical manufacturing and regulated laboratory environments. Strong expertise in HPLC, GC, FTIR, stability testing, method validation, and OOS investigations. Recognized for precision, data integrity, and regulatory compliance within FDA-regulated settings. Proven ability to support batch release, validation activities, and cross-functional quality initiatives.
Overview
6
6
years of professional experience
Work History
Analytical Chemist
American Spray Tech
11.2022 - 06.2025
- Performed analytical testing of pharmaceutical aerosol and drug products using HPLC, GC, and FTIR under GMP conditions.
- Supported method validation, verification, and transfer activities in alignment with FDA and ICH standards.
- Conducted stability studies and ensured accurate, audit-ready documentation.
- Investigated OOS/OOT results and partnered with QA to determine root cause and implement corrective actions.
- Maintained calibration and performance qualification of analytical instruments.
- Collaborated with manufacturing and QA to support batch release and regulatory compliance.
- Pharmaceutical Manufacturing
Chemist
L’Oréal
11.2021 - 12.2022
- Conducted raw material and finished product testing using HPLC, GC, FTIR, and UV-Vis.
- Ensured compliance with quality standards and GLP documentation practices.
- Supported product investigations and continuous improvement initiatives.
Graduate Research Assistant
Brooklyn College
01.2019 - 05.2021
- Synthesized and characterized compounds using NMR, HPLC, IR, and LC/MS.
- Conducted antimicrobial research on gold-antibiotic complexes.
- Maintained detailed laboratory notebooks and presented technical findings.
- Trained undergraduate students in laboratory procedures and safety protocols.
- Department of Chemistry
Education
Master of Science - Chemistry
Brooklyn College
Bachelor of Science - Chemistry
Fakulteti i Shkencave të Natyrës
Tirana, AlbaniaSkills
- GMP / GLP Compliance
- FDA-Regulated Manufacturing
- Analytical Method Validation & Verification
- Stability Testing (ICH Guidelines)
- OOS / OOT Investigation & CAPA Support
- Batch Release Testing
- Instrument Calibration & Maintenance
- SOP Adherence & Audit Readiness
- Data Integrity & Technical Documentation
- Instrumentation: HPLC
- Instrumentation: GC
- Instrumentation: FTIR
- Instrumentation: LC/MS
- Instrumentation: NMR
- Instrumentation: UV-Vis
Languages
English
Italian
Albanian
Core Pharmaceutical Expertise
- GMP / GLP Compliance
- FDA-Regulated Manufacturing
- Analytical Method Validation & Verification
- Stability Testing (ICH Guidelines)
- OOS / OOT Investigation & CAPA Support
- Batch Release Testing
- Instrument Calibration & Maintenance
- SOP Adherence & Audit Readiness
- Data Integrity & Technical Documentation
- Instrumentation: HPLC | GC | FTIR | LC/MS | NMR | UV-Vis
Timeline
Analytical Chemist
American Spray Tech
11.2022 - 06.2025
Chemist
L’Oréal
11.2021 - 12.2022
Graduate Research Assistant
Brooklyn College
01.2019 - 05.2021
Bachelor of Science - Chemistry
Fakulteti i Shkencave të Natyrës
Master of Science - Chemistry
Brooklyn College