Quality Control Specialist

Company: Latitude, Inc.
Location: Sanford
Posted on: August 3, 2022

Job Description:

Pay: 35-45/hr (Salaried with overtime opportunity) -The Quality Control Specialist I will:

• Perform quality control procedures for clinical trials managed by the Clinical Operations department; review all study documentation for accuracy, consistency, and completeness.
• Work with the QC manager to schedule live and post-visit QC activities to ensure that all requirements of the QC plan are executed
• Work with QC manager and QC Specialists to ensure study specific QC plans are followed during clinical trials, ensuring QC processes are in alignment with Cliantha Research SOPs and study protocols
• Assist with the development of; and utilize QC checklists and other QC tools designed to document/track the QC review process
• Communicate findings from QC reviews to the appropriate Clinical Operations staff via QC summaries, reports or verbally as required under the guidance of QC manager/QC Specialists.
• With some guidance, follow-up on all QC findings, as required, until a satisfactory resolution has been determined.
• Maintain a working knowledge of relevant US, Canadian and European GxP regulations as well as ICH regulations.
• Ensure compliance with appropriate Cliantha Research SOPs, GCP and ICH guidelinesWhat youll bring:To perform this job successfully, an individual must have:
  • Prefer a bachelors degree, with a minimum of two years of college, university, or technical school education in life science or relevant scientific discipline.
  • 0-2 years of relevant experience in a clinical research setting
  • Displays a basic ability to identify, anticipate and define issues in a timely manner and to understand the potential impact of issues. Sufficient awareness to notify a supervisor when the problem is beyond the individuals ability to resolve, or as otherwise appropriate. Knowledge of the IRB process, ICH GCP and FDA requirements
  • Strong documentation skills and high attention to detailPowered by JazzHR

Keywords: Latitude, Inc., Sanford , Quality Control Specialist, Other , Sanford, Florida