Apply Buddy
support@applybuddy.ai | (123) 456-7899 | Silicon Valley, CA
Professional Summary
Senior Chemist with a track record of developing and transferring analytical methods, leading CAPA, and passing FDA and ISO 17025 audits. Mentors analysts and keeps laboratories reliable and compliant.
Professional Experience
- Developed a stability-indicating HPLC method resolving the active from five degradants, cutting run time 25%.
- Directed a QC team of six releasing 500+ samples monthly at 97%+ on-time while holding ISO 17025 accreditation.
- Served as SME in an FDA GMP inspection, closing with zero 483 observations in the QC laboratory.
- Transferred validated HPLC methods to two contract labs with comparative testing within 2% agreement.
- Led OOS and CAPA program, reducing recurring out-of-specification results by 40% year over year.
- Qualified new ICP-MS and GC-MS systems via IQ/OQ/PQ, expanding trace-metal capacity by 20%.
- Analyzed drinking-water trace metals by ICP-MS per EPA Method 200.8 across 300+ samples at low-ppb levels.
- Maintained ISO 17025 quality elements including proficiency testing and uncertainty budgets.
- Trained four analysts on instrument operation and documentation, cutting ramp time from eight weeks to five.
Skills
Method Development, Method Transfer, HPLC, GC-MS, ISO 17025, CAPA Leadership, Stability Program Management, Team Mentoring
Education
Certifications
- GMP Documentation Training
- ISO 17025 Internal Auditor
- ASQ Certified Quality Auditor