Quality Control and Reports Coordinator II

BAS EVANSVILLE INC; Mount Vernon (IN); On-site; USD 60,000 - 85,000; Full time

Benefits offered by this job

Health and dental coverage

Short- and long-term disability

Paid time off

401K

Job summary

Inotiv seeks a Quality Control and Reports Coordinator II to compile data into Toxicology Reports with tables and appendices, ensuring accuracy and professionalism. The role includes GLP and non-GLP report preparation, data package assembly, and CTD table review in collaboration with Study Directors and QA staff.

The position involves thorough data review of Clinical Pathology data and document finalization, with potential archiving and compliance checks across multiple templates and formats.

Qualifications

• Requires familiarity with GLP regulations, SOPs and study protocols/amendments.
• Ability to generate GLP and non-GLP toxicology reports using templates and formatting standards.
• Experience reviewing Clinical Pathology data and CTD Tables for accuracy and compliance.

Responsibilities

• Compile and generate Toxicology Reports with appropriate tables, appendices and contributor reports.
• Prepare Data Packages and GLP compliance drafts and final reports.
• Review and QC Clinical Pathology data and CTD Tables against raw data and protocols.
• Coordinate with Study Directors, QA, and other staff to finalize audited reports.

Skills

Attention to detail

Strong organizational skills

Accurate documentation

Quality assurance

Timeliness

Education

Associate’s Degree or higher in related sciences

Tools

Provantis

Ascentos

LIMS

Microsoft Word

Microsoft Excel

Adobe PDF

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 followingUnderstand, apply, and maintain adherence to GLP regulations, Standard Operating Procedures (SOPs) and Study Protocols/AmendmentsAbility to generate a Non-GLP or GLP Main Toxicology Report Word Document, following templates, formatting, and standardsUnderstanding of all forms of data involved and generated for a Non-GLP or GLP Report and ability to incorporate into a PDFCollaborate 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 ReportsConfirm disposition of Study specimens (Test Article formulations, blood samples, preserved tissues, etc.) at Report Finalization and perform appropriate Archiving activitiesPerform 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 individualReview data pack PDFs, and integrated draft or final report PDFs that have not been reviewed, quality checked, or editedPerform other duties as assigned by Supervisor or appropriate personnelPosition Requirements:Preferred Education and ExperienceAssociate’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 ControlPerformance 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 AbilitiesAbility to follow strict timelinesAbility to demonstrate strong organizational skillsAbility to pay close attention to detailAbility to perform accurate, concise documentation and accurately proofread documents or dataAbility to work with critical reporting software systems (Microsoft Word, Excel, Adobe PDF, Provantis, Ascentos, etc.) and scanned documents and image filesAbility to interact respectfully and professionally with staff and external contactsAbility to adhere to the SOPs and guidelines that protect the integrity of confidential informationPhysical ActivityThis position will require frequent sitting, screen/monitor use and studious activities for extended periods of timeMay require additional hours/overtimeMay 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 terrainPotential Working ConditionsPotential exposure to animal dander and/or materialAbility to work in an environment with mild/moderate noise level or distractionPotential 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 requiredMantoux TB test with negative result may be requiredMaintenance of personal protection through the use of latex or nitrile gloves, dust mask and/or respirator, and safety glasses may be requiredTools, Equipment, & Other Resources UsedVarious 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 DatabasesMicrosoft 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.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.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!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.