Quality Control and Reports Coordinator II

Inotiv•Evansville, IN

56d•Onsite

About The Position

The Quality Control and Reports Coordinator II is responsible for compiling and generating all collected data into a Toxicology Report with appropriate Tables, Appendices and Contributor Reports. This position ensures that the Report written, in its entirety, is accurate, consistent, and professional. Level II also assumes responsibility for Data Packages, preparation of Good Laboratory Practice (GLP) Compliant and Non-GLP Draft and Final Reports. In addition, Level II will also be responsible for the thorough review of specific Clinical Pathology Data on a regular basis, and Common Technical Document (CTD) Tables, as needed by Study Directors.

Requirements

Associate’s Degree or higher in related sciences and/or at least 2 – 4 years’ experience in research as a Laboratory Animal Technician or Quality Assurance/Quality Control
Ability to follow strict timelines
Ability to demonstrate strong organizational skills
Ability to pay close attention to detail
Ability to perform accurate, concise documentation and accurately proofread documents or data
Ability to work with critical reporting software systems (Microsoft Word, Excel, Adobe PDF, Provantis, Ascentos, etc.) and scanned documents and image files
Ability to interact respectfully and professionally with staff and external contacts
Ability to adhere to the SOPs and guidelines that protect the integrity of confidential information

Responsibilities

Shows efficiency in Level I Responsibilities and Duties along with the following
Understand, apply, and maintain adherence to GLP regulations, Standard Operating Procedures (SOPs) and Study Protocols/Amendments
Ability to generate a Non-GLP or GLP Main Toxicology Report Word Document, following templates, formatting, and standards
Understanding of all forms of data involved and generated for a Non-GLP or GLP Report and ability to incorporate into a PDF
Collaborate with Study Directors, Quality Assurance Auditors, fellow Report Writers, third parties or other appropriate personnel to prepare Non-GLP or GLP Audited Draft Reports and Final Toxicology Reports
Confirm disposition of Study specimens (Test Article formulations, blood samples, preserved tissues, etc.) at Report Finalization and perform appropriate Archiving activities
Perform thorough review/Quality Check of Clinical Pathology generated Data Tables in comparison to raw data for accuracy and compliance to the Protocol/Amendment and appropriate SOPs
Perform thorough review/Quality Check of CTD Tables upon completion by the Study Director or assigned individual
Review data pack PDFs, and integrated draft or final report PDFs that have not been reviewed, quality checked, or edited
Perform other duties as assigned by Supervisor or appropriate personnel