Quality Control and Reports Coordinator II
Inotiv
Summary
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.
Job description
Responsibilities and Duties
- 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
Position Requirements
Preferred Education and Experience: 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
General Abilities
- 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
Requirements
- Associate's Degree or higher in related sciences
- 2 – 4 years' experience in research as a Laboratory Animal Technician or Quality Assurance/Quality Control
- Ability to follow strict timelines
- Strong organizational skills
- Attention to detail
- Accurate, concise documentation and proofreading
- Proficiency with Microsoft Word, Excel, Adobe PDF, Provantis, Ascentos
- Professional interaction with staff and external contacts
- Adherence to SOPs and confidentiality guidelines
Benefits
- Health insurance
- Dental coverage
- Short-term disability
- Long-term disability
- Paid time off
- Paid parental leave
- 401(k)
Company overview
Inotiv is a leading contract research organization (CRO) specializing in nonclinical research services for the pharmaceutical, biotechnology, and medical device industries. The company provides comprehensive solutions including discovery and safety assessment services, research models, and analytical support. Inotiv operates through two main segments: Research Models and Services (RMS) and Discovery and Safety Assessment (DSA). The RMS segment offers research models, including purpose-bred rodents and large research models, along with related services. The DSA segment provides drug discovery and development services, including in vitro and in vivo studies, bioanalytical services, and regulatory support. With facilities across North America and Europe, Inotiv serves a global client base, supporting the development of new therapeutics from early discovery through regulatory submission. The company plays a critical role in advancing biomedical research by providing essential preclinical data and models that help accelerate the development of new drugs and medical treatments.