Quality Control and Reports Coordinator I

inotivco; Evansville (IN); On-site; USD 42,000 - 56,000; Full time

Job summary

Inotiv seeks a Quality Control and Report Coordinator Level I to review and organize study data, ensuring GLP, SOPs, and protocol compliance. You will perform data quality checks in Provantis or Ascentos, generate data tables, and collaborate with histology and other departments to support timely reporting.

The role emphasizes attention to detail, strong organizational skills, and accurate documentation, with on-site responsibilities in Evansville, Indiana.

Qualifications

• Associate's Degree or higher in related sciences or equivalent.
• Up to 1 year of experience in research as a Laboratory Animal Technician or QA/QC preferred.

Responsibilities

• Perform quality checks of raw data in Provantis or Ascentos for consistency, completeness, accuracy, and SOP/regulation compliance.
• Verify findings from raw data or LIMS and coordinate responses with the appropriate personnel.
• Review study protocols, amendments, schedules, and calendars.
• Ensure adherence to GLP, SOPs, and study protocols and amendments.
• Collate and organize raw data records in study binders.
• Understand the purpose and procedure of all data collection forms.
• Generate and access data within Provantis or Ascentos as needed.
• Generate Data Tables in Provantis or Ascentos as needed.
• Compile Data Tables for review by Pathologists upon request.
• Prepare table and appendix keys for Clinical Pathology as needed.
• Assist with maintenance and QC of maintenance logs and animal data records.
• Maintain positive interdepartmental working relationships.
• Participate in study initiation meetings.
• Perform additional duties as assigned.

Skills

Attention to detail

Organizational skills

Documentation

Professional communication

Adherence to SOPs

Education

Associate's Degree or higher in related sciences

Up to 1 year of research experience

Tools

Provantis

Ascentos

Microsoft Excel

Microsoft Word

Adobe Acrobat

Job description

The Quality Control and Report Coordinator Level I position is responsible for the review, Quality Check, and organization of all Study data collected manually and electronically. 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.

Position 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 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

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

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.)

Physical Activity

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 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

#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 adva