Quality Control Reports Coordinator I

Inotiv, Inc.; Evansville (IN); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Health and dental coverage

Paid time off

401K plan

Parental leave

Disability insurance

Job summary

Inotiv, Inc. is seeking a Quality Control and Report Coordinator I to review and quality-check study data collected manually and electronically. You will ensure consistency, completeness, and GLP/SOP compliance across datasets and assist in compiling data into Data Tables.

The role is on-site in First Shift, with exposure to lab environments. You will work with Provantis, Ascentos, and other databases, maintaining accuracy and timely documentation for pathologists and study teams.

Qualifications

• Review/Quality Check of raw data for consistency, completeness and compliance with Protocol and SOPs.
• Understand and apply GLP regulations and study protocols.
• Collate and organize raw data records within study binders.

Responsibilities

• Perform thorough review/Quality Check of raw data and electronically entered information for accuracy and compliance.
• Verify and address findings from raw data and coordinate responses from appropriate personnel.
• Review Study Protocols, Amendments, schedules, and calendars.
• Generate Data Tables within Provantis or Ascentos as needed.
• Prepare corresponding Table/Appendix keys for Clinical Pathology as needed.
• Assist with maintenance and filing of logs and facility records.

Skills

Attention to detail

Organizational skills

Time management

Documentation

Data review

Education

Associate's Degree or higher in related sciences

Tools

Provantis

Ascentos

LIMS

PDS

Master Control

Excel

Word

PowerPoint

PDF

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.

First Shift - On-site

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 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

#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!

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.