Performs and documents audits of preclinical research study activities, data and reports to ensure their accuracy and compliance with Good Laboratory Practice (GLP) regulations, ISO17025 requirements, study protocols and laboratory Standard Operating Procedures (SOPs). Reviews protocols and amendments for GLP compliance, accuracy and compliance with US and international testing guidelines, and performs and documents critical phase inspections during study conduct.
- Bachelor degree or equivalent, preferably in a scientific discipline field.
- RQAP-GLP, ISO17025, ASQ Quality Auditor or Quality Manager certifications are preferred.
- Minimum of 4 years GXP auditing experience in a preclinical laboratory environment and experience in preclinical medical device research.
- Working knowledge of GLP and ISO17025 regulations and the ability to interpret and apply these to daily work.
- Working knowledge of laboratory procedures and computer validated data collection systems in a preclinical environment.
- Must be able to clearly speak, write, read, and understand English, including the ability to understand and verify scientific text and data.