6376 - Audit Trail Reviewer - QC Laboratory Systems / Quality Specialist
External
Veristainc · Bloomington, INPrepare for this interview
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About the role
Verista's 500 experts team up with the world's most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world's most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities. Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day. Company Culture Guidelines & Values: We empower and support our colleagues We commit to client success at every turn We have the courage to do the right thing We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged. We constantly acquire new skills and learn from our experiences to enhance our collective expertise 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.
Responsibilities
- Perform audit trail reviews for assigned systems (manufacturing or 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 staff to transition systems into the new ATR program.
- Take detailed notes during system familiarization to aid in documentation creation.
Requirements
- 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.
- *Verista is an equal opportunity employer.
- National (US) Range
- $59,951 - $104,500 USD
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