007V5972 Audit Trail Reviewer - Manufacturing SystemsTwo River Consulting Partners • Bloomington, IN, US
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007V5972 Audit Trail Reviewer - Manufacturing Systems
Two River Consulting Partners • Bloomington, IN, US
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job_description.job_card.job_descriptionExperience in manufacturing (filling and packaging) 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. Must have the ability to work onsite in Bloomington, IN 6 month contract with potential extension up to 1 year
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 manufacturing production 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 (manufacturing), 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
LOCATION
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Manufacturing System • Bloomington, IN, US