Contractor Data Integrity Specialist — GXP & Audit Trails

Curium Pharma; Noblesville (IN); On-site; USD 70,000 - 90,000; Full time

Job summary

Curium Pharma in Noblesville, IN seeks a Contractor Data Integrity Specialist to support electronic and equipment systems at the facility.

The role centers on assessing data integrity, reviewing system documentation, and ensuring compliance with FDA, EP, and international guidelines while maintaining audit-ready records. Core tasks include data review, access controls, and remediation of gaps.

Qualifications

• Three or more years of relevant work experience understanding and interpreting cGMP, GLP or GCP regulations with a focus on Data Integrity requirements.
• Experience reviewing / authoring standard operating procedures (SOPs) and regulatory documents.
• Proficiency with core software (Word, Excel, SharePoint, Project) and documenting assessments.

Responsibilities

• Review system documentation (e.g., user manuals, SOPs, validation reports).
• Analyze audit trails for data manipulation, deletions or unauthorized access.
• Review data for completeness, accuracy, and consistency.
• Assess data backup and recovery procedures.
• Evaluate user access controls and permissions.
• Identify and remediate data integrity gaps and deficiencies.
• Document assessment findings, recommendations, and regulatory alignment.

Skills

Data Integrity

cGMP compliance

Regulatory understanding

Analytical thinking

Documentation review

Education

Bachelor’s degree preferred

Tools

Microsoft Word

Excel

SharePoint

Project

Job description

Curium Pharma in Noblesville, IN seeks a Contractor Data Integrity Specialist to support electronic and equipment systems at the facility.

The role centers on assessing data integrity, reviewing system documentation, and ensuring compliance with FDA, EP, and international guidelines while maintaining audit-ready records. Core tasks include data review, access controls, and remediation of gaps.