What are the responsibilities and job description for the Good Laboratory Practice Expert position at Viltis?
As a Good Laboratory Practice Expert, you will be responsible for ensuring compliance with 21 CFR Part 58 regulations and Good Laboratory Practice (GLP) standards. You will conduct phase audits, data audits, and facility audits to assess compliance and identify areas for improvement.
The ideal candidate will have extensive experience in GLP QA auditing, with a strong understanding of 21 CFR Part 58. Hands-on experience with phase audits, data audits, and facility audits in a GLP environment is also required. Additionally, proficiency in HPLC, including the ability to assist scientists with HPLC-related questions and troubleshooting, is essential.
You will provide guidance and support to laboratory personnel, addressing regulatory and quality-related questions. You will also review and assess HPLC-related data and documentation for GLP compliance. The successful candidate will be able to work onsite at least 3 days per week in Hopewell, NJ, with a 40-hour workweek.