Toxicology Reports & Data Coordinator II

BAS EVANSVILLE INC; Mount Vernon (IN); On-site; USD 60,000 - 85,000; Full time

Benefits offered by this job

Health and dental coverage

Short- and long-term disability

Paid time off

401K

Job summary

Inotiv seeks a Quality Control and Reports Coordinator II to compile data into Toxicology Reports with tables and appendices, ensuring accuracy and professionalism. The role includes GLP and non-GLP report preparation, data package assembly, and CTD table review in collaboration with Study Directors and QA staff.

The position involves thorough data review of Clinical Pathology data and document finalization, with potential archiving and compliance checks across multiple templates and formats.

Qualifications

• Requires familiarity with GLP regulations, SOPs and study protocols/amendments.
• Ability to generate GLP and non-GLP toxicology reports using templates and formatting standards.
• Experience reviewing Clinical Pathology data and CTD Tables for accuracy and compliance.

Responsibilities

• Compile and generate Toxicology Reports with appropriate tables, appendices and contributor reports.
• Prepare Data Packages and GLP compliance drafts and final reports.
• Review and QC Clinical Pathology data and CTD Tables against raw data and protocols.
• Coordinate with Study Directors, QA, and other staff to finalize audited reports.

Skills

Attention to detail

Strong organizational skills

Accurate documentation

Quality assurance

Timeliness

Education

Associate’s Degree or higher in related sciences

Tools

Provantis

Ascentos

LIMS

Microsoft Word

Microsoft Excel

Adobe PDF

Job description

Inotiv seeks a Quality Control and Reports Coordinator II to compile data into Toxicology Reports with tables and appendices, ensuring accuracy and professionalism. The role includes GLP and non-GLP report preparation, data package assembly, and CTD table review in collaboration with Study Directors and QA staff.

The position involves thorough data review of Clinical Pathology data and document finalization, with potential archiving and compliance checks across multiple templates and formats.