Apply Buddy
support@applybuddy.ai | (123) 456-7899 | Silicon Valley, CA
Professional Summary
Senior Laboratory Technician and Lab Lead who validates methods, authors SOPs, trains analysts, and supports audits. Combines deep instrumentation expertise with strong quality-system ownership across a busy analytical section.
Professional Experience
- Led validation of a new HPLC assay, establishing accuracy, precision, and linearity per ICH guidelines before deployment.
- Supported a successful ISO 17025 audit, organizing calibration and traceability records and closing all findings within 30 days.
- Trained four new technicians on HPLC operation and LIMS documentation, verifying competency sign-offs before independent work.
- Performed dissolution and content-uniformity testing per USP methods, releasing 30+ lots monthly within GMP timelines.
- Investigated and documented out-of-specification results, identifying root causes that reduced repeat OOS events 25%.
- Authored and revised SOPs for sample prep and instrument operation, standardizing methods across two benches.
- Analyzed water and soil samples by GC-MS and ICP-MS against EPA methods with full chain-of-custody documentation.
- Maintained 99% instrument uptime through scheduled preventive maintenance and calibration.
- Processed 60+ samples per shift while maintaining GDP-compliant records with zero critical findings.
Skills
Method Validation, SOP Development, Analyst Training, Audit Support, Instrument Qualification, GMP / ISO 17025, Quality Control, Troubleshooting
Education
Certifications
- GMP / GLP Training
- ISO 17025 Internal Auditor Awareness
- Lab Safety / Chemical Hygiene Certification