Senior Quality Assurance Specialist

4 days ago


Mount Vernon, United States Inotiv Full time
Company Overview

Inotiv is a growing contemporary drug discovery and development company where we take pride in our work and strive for excellence in the delivery of world-class drug discovery and development solutions. Our team is dedicated to impacting the health and well-being of people all over the world.


Job Description

We are seeking an experienced Senior Quality Assurance Specialist, Quality Control and Data Coordinator, or Data Compliance Specialist to join our team. The successful candidate will be responsible for reviewing, quality checking, and organizing study data that is manually and electronically collected. They will thoroughly inspect the data for consistency, completeness, and compliance with Study Protocols, Good Laboratory Practice (GLP), Standard Operating Procedures (SOPs), and other applicable regulations.


Responsibilities
  • 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
  • Compile Data Tables with information that has yet to be thoroughly reviewed or Quality Checked, which will subsequently be viewed by Pathologists

Salary and Benefits

The estimated annual salary for this role is $$64,500, commensurate with experience and responsibilities. In addition to a competitive salary, we offer comprehensive benefits including health and dental coverage, short- and long-term disability, paid time off, paid parental leave, 401K, and more.


Requirements

To be considered for this role, you should have a strong educational background and/or relevant experience in quality assurance, data management, or a related field. A combination of advanced levels of education and/or years of experience may also be considered.



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