Quality Control Reports Coordinator

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.

• 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

• 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,