Quality Control and Reports Coordinator II

Inotiv; Evansville (IN); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health and dental coverage

Paid time off

401K

Job summary

Inotiv seeks a Quality Control and Reports Coordinator II to compile data into Toxicology Reports with proper tables and appendices. This role ensures the full report is accurate, consistent, and professional, and oversees data packages and GLP and non-GLP draft/final reports.

The position includes reviewing Clinical Pathology data, CTD tables, and coordinating with Study Directors and QA auditors to produce audited reports.

Qualifications

• Understanding and adherence to GLP regulations and SOPs.
• Ability to generate Non-GLP or GLP main toxicology reports per templates and standards.
• Ability to manage data forms and incorporate into PDFs with accuracy.
• Collaborate with Study Directors, QA Auditors and third parties to prepare audited reports.

Responsibilities

• Understand, apply, and maintain adherence to GLP SOPs and study protocols/amendments.
• Generate GLP/Non-GLP main toxicology reports following templates and standards.
• Incorporate data into PDFs and ensure accurate formatting.
• Collaborate with Study Directors, QA Auditors, and others to prepare audited reports.
• Confirm disposition of study specimens at finalization and perform archiving.
• Review Clinical Pathology data tables for accuracy against raw data.
• Review CTD tables upon completion by the study director or assigned individual.
• Review data pack PDFs and integrated drafts/final reports not yet reviewed.
• Perform other duties as assigned by supervisor or appropriate personnel.

Skills

Attention to detail

Strong organizational skills

Time management

Written communication

Education

Associate's Degree or higher in related sciences and/or 2-4 years' experience in research

Tools

Microsoft Word

Microsoft Excel

Adobe Acrobat PDF

Provantis

Ascentos

LIMS

Job description

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 required
• Mantoux TB test with negative result may be required
• Maintenance of personal protection through the use of latex or nitrile gloves, dust mask and/or respirator, and safety glasses may be required

Tools, Equipment, & Other Resources Used

• Various software applications sustained by a WindowsTM Microsoft platform (Excel, Word, PowerPoint, etc.), and Adobe Acrobat - Portable Document Formatting (PDF)
• Enterprise Service Management (ESM), Master Control, Watson Laboratory Information Management System (LIMS), Projects Database System (PDS), Provantis, Ascentos, and other Databases
• Microsoft Access (Outlook, Teams, Dynamics365, etc.)

#LI-MP1 #LI-Onsite

*This position could be offered at different levels for candidates who qualify with a combination of advanced levels of education and/or years of experience. The salary range will adjust along with the level of the role to match the person's relevant experience and/or education level.

Salary will be commensurate with experience and responsibilities. Benefits include health and dental coverage, short- and long-term disability, paid time off, paid parental leave, 401K, and more!

At Inotiv, our work helps advance the development of new medicines and therapies that can improve people's lives. As a leading global contract research organization (CRO), we partner with researchers to tackle complex scientific challenges, drive innovation, and help build a healthier, safer world. Bringing together scientists, researchers, technical experts, and business professionals, we provide the expertise and collaboration needed to move research forward. Our people make this work possible, and we value the knowledge, ideas, and contributions each person brings to the team. Whether you are starting your career or bringing years of experience, Inotiv offers opportunities to learn, grow, and play a meaningful role in advancing treatments for patients around the world.

Inotiv is an Equal Opportunity Employer. It is our policy to provide a fair and equal employment opportunity to all persons, regardless of age, race, color, religion, sex, gender, gender identity, gender expression, sexual orientation, genetic information, disability, national origin, veteran status, or any other basis prohibited by law. This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination and access to benefits and training.