Quality Control Reports Coordinator I
Inotiv
Summary
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.
Job description
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 Windows 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.)
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
Requirements
- Associate's Degree or higher in related sciences
- Up to a year of experience in research as a Laboratory Animal Technician or Quality Assurance/Quality Control
- Ability to follow strict timelines
- Strong organizational skills
- Attention to detail
- Accurate, concise documentation and proofreading
- Ability to work with Microsoft Word, Excel, Adobe PDF, Provantis, Ascentos
- Ability to interact respectfully and professionally
- Adherence to SOPs and confidentiality guidelines
Benefits
- Health insurance
- Dental coverage
- Short-term disability
- Long-term disability
- Paid time off
- Paid parental leave
- 401(k)
Company overview
Inotiv is a leading contract research organization (CRO) specializing in nonclinical research services for the pharmaceutical, biotechnology, and medical device industries. The company provides comprehensive solutions including discovery and safety assessment services, research models, and analytical support. Inotiv operates through two main segments: Research Models and Services (RMS) and Discovery and Safety Assessment (DSA). The RMS segment offers research models, including purpose-bred rodents and large research models, along with related services. The DSA segment provides drug discovery and development services, including in vitro and in vivo studies, bioanalytical services, and regulatory support. With facilities across North America and Europe, Inotiv serves a global client base, supporting the development of new therapeutics from early discovery through regulatory submission. The company plays a critical role in advancing biomedical research by providing essential preclinical data and models that help accelerate the development of new drugs and medical treatments.