Apply Buddy
support@applybuddy.ai | (123) 456-7899 | Silicon Valley, CA
Professional Summary
Chemist with practical experience validating analytical methods and closing GMP investigations across HPLC, GC-MS, and stability programs. Known for defensible data and reliable on-time release.
Professional Experience
- Validated a stability-indicating HPLC assay per ICH Q2, achieving R-squared 0.999 and RSD under 2%.
- Led OOS investigations and CAPA that cut recurring out-of-specification results by 40% year over year.
- Released 25+ GMP drug-product batches monthly against USP monographs at 99% on-time turnaround.
- Ran headspace GC-MS residual-solvent testing per USP <467> at ppm-level detection limits.
- Designed ICH stability pulls at 25C/60%RH and 40C/75%RH tracking assay and impurity trends.
- Authored 10 analytical SOPs, reducing method-related deviations by 30% across shifts.
Skills
HPLC, GC-MS, Method Validation, Stability Studies, OOS Investigation, GMP, LIMS, Instrument Qualification
Education
Certifications
- GMP Documentation Training
- OSHA Laboratory Safety
- ASQ Certified Quality Improvement Associate