About the Role

The Senior QA Auditor, GLP is responsible for carrying out systematic and independent examination (i.e., audit) of multiple study-related activities and documents to determine whether the activities were conducted and data were recorded, analyzed and accurately reported according to the protocol, SOPs, GLP (21 CFR Part 58 and Part 11), and applicable regulatory requirements. The Senior QA Auditor reports findings to the Study Director or Responsible Person and Testing Facility Management, builds and maintains effective working relationships throughout the organization, and mentors/coaches lower-level staff.

What You'll Do

• Audit phases of nonclinical and laboratory studies, reports, and perform related duties (e.g., issue audits and QA statements) to ensure regulatory compliance.
• Audit all disciplines (e.g., Method Validations, Non-Clinical GLP Studies).
• Perform process audits, vendor qualifications, equipment and soft...