VAudit Trail Reviewer – QC Lab Systems​/Quality Specialist Consultant

0054V6376 Audit Trail Reviewer – QC Lab Systems/Quality Specialist Consultant Position Summary

We are seeking a dedicated Audit Trail Reviewer to support our Data Integrity (DI) program through continuous and periodic audit trail reviews. One role will focus on manufacturing production systems, and the other on QC laboratory systems. Cross-functional support between the two areas may be required based on operational demand.

• Perform audit trail reviews for assigned systems (manufacturing or QC lab), ensuring compliance with DI standards.
• Identify and elevate suspicious or non-compliant activities within audit trails.
• Document findings and maintain accurate records of reviews.
• Support the development of documentation including parameter lists, work instructions, and training materials.
• Collaborate with staff to transition systems into the new ATR program.
• Take detailed notes during system familiarization to aid in documentation creation.

• Experience in either manufacturing (filling and packaging) or QC laboratory environments.
• Strong understanding of Data Integrity principles and regulatory expectations.
• Quality background preferred, with demonstrated ability to assess electronic records for anomalies.
• Prior experience conducting audit trail reviews is highly desirable.
• Excellent documentation and communication skills.
• Ability to work independently and manage priorities effectively.

This role requires the ability to be on-site, full-time in Bloomington, IN.