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 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
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, bases, and other hazardous chemicals, electro-mechanical hazards, flammable materials and biohazards. Due to exposure to hazardous biological materials (which may include HIV positive specimens), immunization to diseases may be…