Tempus Labs, Inc. is hiring a
Senior Quality Specialist

Summary

The Senior Quality Specialist is responsible for coordinating and implementing GCP quality assurance activities, managing audit findings, CAPAs, and Non-conformances, and assisting with sponsor audits. The role also involves working with QA Management and Department Heads to manage training via the LMS.

Requirements

• Bachelor’s degree required
• 5+ years of working and managing controlled documents and training in a regulated environment
• Experience working with QMS elements (e.g., document management, training and compliance, CAPA and non-conformance management, performing root cause analysis (RCA), and quality systems management)
• Knowledge of ICH-GCP guidelines, and other applicable regulatory guidelines

Responsibilities

• Collaborate with QA Management to implement the quality management system (QMS)
• Coordinate and manage Tempus Compass policies, procedures and associated controlled documents throughout the development, review, revision and archiving process
• Ensure processes and procedures are updated to reflect regulatory trends, technological changes and best practices
• Track and perform follow up activities for audit findings, CAPAs and Non-conformances
• Compile trend analyses of GCP quality system metrics such as audit findings, CAPAs and Non-conformances and report to QA Management
• Assist in the preparation and conduct of internal and external audits as needed and ensure compliance with associated processes
• Support concurrent clinical efforts by consulting on projects and representing QA in interactions with internal and external customers
• Interface with clients, internal and external stakeholders, and vendors, as needed
• Support company regulatory GCP inspections, as needed
• Manage, assign and track corporate, regulatory, controlled document and project-specific training via the LMS
• Maintain the master training matrix and update upon release of new, revised or retired controlled documents
• Work closely with management to evaluate and identify trends and training needs
• Report metrics for corporate, regulatory, controlled document and project-specific training compliance trends to QA Management, Department Heads and Project Managers
• Support external controlled requests from sponsors or third party vendors
• Work effectively with cross-functional teams to address and resolve quality issues

Preferred Qualifications

8+ years of supporting a QMS in a Contract Research Organization (CRO) or Pharmaceutical company