GLP-Compliant Toxicology Reports Coordinator II

Inotiv; Evansville (IN); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health and dental coverage

Paid time off

401K

Job summary

Inotiv seeks a Quality Control and Reports Coordinator II to compile data into Toxicology Reports with proper tables and appendices. This role ensures the full report is accurate, consistent, and professional, and oversees data packages and GLP and non-GLP draft/final reports.

The position includes reviewing Clinical Pathology data, CTD tables, and coordinating with Study Directors and QA auditors to produce audited reports.

Qualifications

• Understanding and adherence to GLP regulations and SOPs.
• Ability to generate Non-GLP or GLP main toxicology reports per templates and standards.
• Ability to manage data forms and incorporate into PDFs with accuracy.
• Collaborate with Study Directors, QA Auditors and third parties to prepare audited reports.

Responsibilities

• Understand, apply, and maintain adherence to GLP SOPs and study protocols/amendments.
• Generate GLP/Non-GLP main toxicology reports following templates and standards.
• Incorporate data into PDFs and ensure accurate formatting.
• Collaborate with Study Directors, QA Auditors, and others to prepare audited reports.
• Confirm disposition of study specimens at finalization and perform archiving.
• Review Clinical Pathology data tables for accuracy against raw data.
• Review CTD tables upon completion by the study director or assigned individual.
• Review data pack PDFs and integrated drafts/final reports not yet reviewed.
• Perform other duties as assigned by supervisor or appropriate personnel.

Skills

Attention to detail

Strong organizational skills

Time management

Written communication

Education

Associate's Degree or higher in related sciences and/or 2-4 years' experience in research

Tools

Microsoft Word

Microsoft Excel

Adobe Acrobat PDF

Provantis

Ascentos

LIMS

Job description

Inotiv seeks a Quality Control and Reports Coordinator II to compile data into Toxicology Reports with proper tables and appendices. This role ensures the full report is accurate, consistent, and professional, and oversees data packages and GLP and non-GLP draft/final reports.

The position includes reviewing Clinical Pathology data, CTD tables, and coordinating with Study Directors and QA auditors to produce audited reports.