Review system documentation and conduct assessments to ensure compliance with data integrity standards.
Analyze audit trails and data sets to identify inconsistencies, unauthorized access, or potential manipulation.
Evaluate user access controls, data backup/recovery processes, and overall system practices.
Identify gaps, prioritize risks, and implement or recommend remediation actions.
Document assessment activities, findings, and recommendations in a clear, structured manner.
Maintain compliance with U.S. and international regulations and stay current on data integrity requirements.

Requirements

Bachelor’s degree preferred or equivalent relevant work experience.
3+ years of experience interpreting and applying cGMP, GLP, or GCP regulations with a focus on data integrity.
Strong understanding of regulatory requirements in manufacturing and laboratory environments.
Experience reviewing and/or authoring standard operating procedures (SOPs).
Proficiency with Microsoft Office tools (Word, Excel, SharePoint, Project).

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