Quality Control and Reports Coordinator II

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.

Responsibilities and Duties:

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 SOPsPerform 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 Performance Requirements:
* Characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

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

Physical Activity This position will require frequent sitting, screen/monitor use and studious activities for extended periods of time

May require additional hours/overtime

May require at times reaching while sitting/standing, walking, standing, carrying, lifting (max. 20 lbs.), gripping and twisting hand movements, finger control and other general repetitive motions and may require ability to walk over rough terrain

Potential Working Conditions Potential exposure to animal dander and/or material

Ability to work in an environment with mild/moderate noise level or distraction

Potential involvement with radiant/electrical energy, solvents, grease, oil, irritants, acids,…