Description

You will audit studies, processes, and data to ensure compliance with protocols, regulations, and internal standards.

This role is on-site.

Responsibilities

• Audit studies, reports, and records for accuracy and regulatory compliance.
• Perform in-process inspections of nonclinical study phases and assay methods.
• Follow up on audit findings and support staff as a technical resource for compliance issues.
• Identify and resolve quality discrepancies proactively and diplomatically.

Required Skills

• Bachelor’s degree in a healthcare or relevant scientific field.
• 3+ years of Quality Assurance or laboratory experience.
• Robust knowledge of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP).
• Solid understanding of 21 CFR Part 11 and laboratory standards.
• Required expertise in immunogenicity (NAb and TAb) and ddPCR assays.
• Proven experience conducting audits.
• Proficiency in MS Word, Excel, and PowerPoint.
• Ability to work independently in a matrixed team environment.

Preferred Skills

• Experience in clinical and preclinical laboratory research settings.
• Strong verbal and written communication skills for cross-functional collaboration.

Key Skills

Education

Bachelor's degree