Job Description

KEY RESPONSIBILITIES
We are seeking a dedicated Audit Trail Reviewers to support our Data Integrity (DI) program through continuous and periodic audit trail reviews. This role will focus on QC laboratory systems. Cross-functional support between the manufacturing systems and QC labs systems may be required based on operational demand.

 

RESPONSIBILITIES

• Perform audit trail reviews for assigned systems (QC lab), ensuring compliance with DI standards.  
• Identify and escalate 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 employees to transition systems into the new ATR program.  
• Take detailed notes during system familiarization to aid in documentation creation.  

 

QUALIFICATIONS

• Experience in 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.  

LOCATION

• Must have the ability to work onsite in Bloomington, IN

EMPLOYMENT

• 6 month contract with potential extension up to 1 year  

Job Tags

Contract work,

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