We are seeking a Senior QA Auditor to join our team. This role involves a quick interview process and requires on-site presence.
Key Responsibilities
Conduct thorough and independent audits of study-related activities and documentation to ensure compliance with protocols, SOPs, GLP (21 CFR Part 58 and Part 11), and relevant regulatory requirements.
Report findings to the Study Director and Testing Facility Management.
Foster effective working relationships across the organization and mentor junior staff.
Primary Duties
Audit various phases of nonclinical and laboratory studies and issue QA statements to ensure regulatory compliance.
Perform in-life audits, process audits, vendor qualifications, and equipment/software validation audits.
Lead facility audits to verify compliance with regulations.
Maintain accurate computerized audit records and documentation.
Provide risk-based compliance insights and guidance.
Write and communicate inspection reports clearly to internal clients.
Ensure SOPs relevant to study conduct are current and followed.
Identify opportunities for process improvements based on audit findings and guide related activities.
Notify management of observed trends in quality and compliance.
Qualifications
Bachelor's degree in a scientific discipline or equivalent experience.
2-3 years of relevant technical experience, including at least 2 years in a GLP-regulated environment.
Professional certifications (e.g., RQAP-GLP or ASQ-CQA) are preferred.
Proficient in Microsoft Office Suite.
Commitment to ongoing training in audits, regulatory affairs, and GLP standards.