Quality Control Reports Coordinator I

6 days ago

Mount Vernon IN United States Inotiv Full time
Quality Control Reports Coordinator ILocation : LocationUS-IN-Mount VernonID2024-5093CategoryOtherTypeFull Time - PermanentOverview

The Quality Control and Report Coordinator Level 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.

Monday - Friday, 6:30am - 3pm

Overtime opportunities.

No holidays.

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
  • 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 departments.
  • Participate in Study initiation meetings
  • Perform other duties as assigned by Supervisor or appropriate personnel
  • 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 regulation
Qualifications

*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.

Inotiv is a growing contemporary drug discovery and development company where we "Play to Win" in an industry rich with opportunity. Together, we face challenges and together we win in the delivery of world-class drug discovery and development solutions that impact the health and well-being of people all over the world. There's an opportunity for everyone at all phases of a career, each individual's unique skill set has an impact on the work we conduct. If you have the talent and desire to impact the quality of people's lives, we have the career opportunities to make it happen. Join us in embracing research and science to impact the health and well-being of people all over the world.

Inotiv has been named a 2023 Top Workplace

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.

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