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008V5973 Audit Trail Reviewer - QC Laboratory Systems
008V5973 Audit Trail Reviewer - QC Laboratory SystemsTwo River Consulting Partners • Bloomington, IN, US
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008V5973 Audit Trail Reviewer - QC Laboratory Systems

008V5973 Audit Trail Reviewer - QC Laboratory Systems

Two River Consulting Partners • Bloomington, IN, US
1 day ago
Job type
  • Temporary
Job description

Job Description

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
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