Travere Therapeutics

Senior Laboratory Auditor, Quality Assurance GLP

Travere Therapeutics

full-time

Posted on:

Location Type: Hybrid

Location: San Diego • California • United States

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Salary

💰 $95,000 - $124,000 per year

Job Level

Senior

About the role

  • Actively supporting the implementation of GLP initiatives
  • Leading the execution of quality related activities
  • Conducting audits of pharmaceutical laboratories
  • Evaluating laboratory systems including method validation and sample management
  • Preparing comprehensive audit plans and reports
  • Managing vendor oversight and issue management
  • Conducting investigations of GLP/GCLP Quality Events
  • Leading the development and delivery of laboratory quality and compliance related training

Requirements

  • Bachelor’s degree in related Life Sciences discipline is required; advanced degree preferred
  • 6+ years in drug/biologics development in the biotechnology or pharmaceutical industry
  • 5 years previous GLP Quality Assurance experience in Clinical and/or non-Clinical Research and Development is preferred
  • Minimum of 3 years of experience planning, conducting, and reporting GLP/GCLP audits
  • In-depth knowledge and understanding of global regulations and guidelines including FDA 21 CFR Part 58
  • Strong working knowledge of computerized systems used in laboratories
  • Ability to identify quality issues/discrepancies and effectively manage them
Benefits
  • premium health
  • financial offerings
  • work-life programs
  • well-being offerings
  • wellness and employee support programs
  • life insurance
  • disability
  • retirement plans with employer match
  • generous paid time off
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
GLP initiativesquality assurancemethod validationsample managementaudit planningaudit reportingvendor oversightinvestigations of GLP/GCLP Quality Eventslaboratory quality trainingcompliance training
Soft Skills
leadershipissue managementproblem identificationeffective communication