Quality Control Reports Coordinator I

BAS EVANSVILLE INC; Evansville (IN); On-site; USD 55,000 - 65,000; Full time

Benefits offered by this job

Health and dental coverage

Short- and long-term disability

Paid time off

Paid parental leave

401K

Job summary

Inotiv in Evansville, IN is seeking a Quality Control and Report Coordinator I to review, QC, and organize study data collected both manually and electronically. You will inspect data for consistency, completeness, and protocol compliance under GLP and SOPs.

Responsibilities include data table generation, data verification, and collaboration with histology and other departments. This role emphasizes accuracy, documentation, and adherence to regulations and timelines.

Qualifications

• Associate’s Degree or higher in related sciences; up to a year of experience in research as a Laboratory Animal Technician or QA/QC (preferred).

Responsibilities

• Review/Quality Check of raw data and electronically entered information for consistency and compliance.
• Coordinate responses from appropriate personnel to findings.
• Generate Data Tables and prepare Appendix/Key pages as needed.
• Maintain logs and facility records; support cross-department collaboration.

Education

Associate’s Degree or higher in related sciences

Tools

Provantis

Ascentos

LIMS

PDS

Master Control

Microsoft Access

Job description

The Quality Control and Report Coordinator I position is responsible for the review, Quality Check, and organization of all Study data that is manually and electronically collected. They will thoroughly inspect the data for consistency, completeness, and compliance to the Study Protocol, Good Laboratory Practice (GLP), Standard Operating Procedures (SOPs), and other applicable regulations. Level I will also assist in compilation and generation of this collected data into necessary Data Tables, as needed.

Responsibilities and Duties

• Perform a thorough review/Quality Check of raw data and electronically entered information within the Database (Provantis or Ascentos) for consistency, completeness, accuracy and compliance with Protocol, SOPs, guidelines and regulations
• Verify and address applicable findings from raw data or LIMS and coordinate responses from the appropriate personnel
• Review Study Protocols, Amendments, schedules, and calendars
• Understand, apply, and maintain adherence to GLP regulations, SOPs and Study Protocols and Amendments
• Collate and organize raw data records within Study binders
• Understand the purpose and procedure of all raw data forms
• Generate and access information needed within the appropriate Database (Provantis or Ascentos)
• Efficiently and accurately generate Data Tables within the appropriate Database (Provantis or Ascentos), as needed
• Upon request from the Histology Department and/or other personnel, compile Data Tables with information that has yet to be thoroughly reviewed or Quality Checked, which will subsequently be viewed by Pathologists
• Prepare the appropriate corresponding Table and/or Appendix key pages, as needed by Clinical Pathology
• Assist with maintenance, review/Quality Check, filing and other processes pertaining to Room Maintenance Logs, Animal Data Collection Logs, and other Facility Records
• Maintain a strong and positive working relationship with all departments
• Participate in Study initiation meetings
• 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 up to a year of experience in research as a Laboratory Animal Technician or Quality Assurance/Quality Control
• 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.)

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; 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 50 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

Compensation and Benefits

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.

• Health and dental coverage
• Short- and long-term disability
• Paid time off
• Paid parental leave
• 401K
• More!

Equal Opportunity Employer

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.

At Inotiv, our people are our greatest asset. We are committed to equality, opportunity, and diversity, and treating our colleagues with the dignity and respect they deserve. We strive to ensure that our people achieve their full potential, and that they enjoy a rewarding career with us.

About Inotiv

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.

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!

Recruiter Contact

We’re looking for people who will help us grow and support our shared purpose: to help our clients discover and develop life-changing therapies for people around the world. As a leading contract research organization (CRO), Inotiv supports discovery and nonclinical development through investigational new drug (IND) and beyond. By leveraging our deep expertise and scientific capabilities, we help you increase efficiency, improve data, and reduce the cost of taking new drugs to market. By providing critical research models and related services, we help researchers realize the full potential of their R&D projects, all while working together to build a healthier and safer world.