DIANA MERCER
Analytical Chemist III
Rahway, NJ · d.mercer@email.com · (555) 295-8817
Summary
Analytical chemist with 9 years of experience in pharmaceutical method development and GMP quality control. Validated 20+ HPLC and GC-MS methods and supported 4 FDA inspections with zero data-integrity findings.
Experience
Analytical Chemist III · Merck & Co.
2019 - Present
- Validate HPLC and GC-MS methods for 15+ drug substances, cutting average analysis time by 35%
- Analyze 250+ stability and release samples monthly, maintaining a 99.5% on-time reporting rate
- Supported 3 FDA pre-approval inspections with zero data-integrity or method-validation findings
- Mentor 4 junior chemists on USP <621> chromatography practice and GMP documentation standards
Analytical Chemist II · Thermo Fisher Scientific
2015 - 2019
- Developed and validated 8 new dissolution and assay methods in compliance with USP/ICH guidelines
- Led root-cause investigations for 30+ out-of-specification results, reducing recurrence by 45%
- Qualified 6 Agilent 1260 HPLC systems and 2 GC-MS units, cutting instrument downtime by 25%
Laboratory Technician · Catalent Pharma Solutions
2013 - 2015
- Prepared 400+ standards and mobile phases monthly for HPLC and UV-Vis testing benches
- Performed Karl Fischer titration and loss-on-drying testing on 60 raw-material lots per quarter
- Logged sample chain-of-custody in LIMS with 100% accuracy across two annual internal audits
Education
B.S. Chemistry — Rutgers University · 2015
Skills
HPLC, GC-MS, Method Validation, GMP, ICP-MS, Titration, LIMS, USP/ICH Guidelines, Stability Testing, Root Cause Analysis, Spectroscopy
Certifications
ASQ Certified Quality Auditor (CQA), American Society for Quality
Certified Six Sigma Green Belt (CSSGB), American Society for Quality
Certified Chemical Hygiene Officer (CCHO), National Registry of Certified Chemists
Projects
Stability Program Rebuild - restructured 30 study protocols into a single LIMS workflow
Impurity Profiling Study - identified 4 degradants by LC-MS/MS ahead of an ANDA filing




