Senior Quality Assurance Specialist — Remote, Rare Disease Impact

Travere Therapeutics; Minneapolis (MN); On-site; USD 95,000 - 124,000; Full time

Job summary

Travere Therapeutics in San Diego, CA, is seeking a Senior Specialist, Quality Assurance Technical to support qualification/validation documents and product transfer activities for solid oral dose and biologic programs, ensuring quality and regulatory compliance.

You will work with cross-functional teams, review protocols and reports, manage QMS workflows, and contribute to CAPA, change controls, investigations, and training to develop expertise and advance therapies for rare diseases.

Qualifications

• 5+ years of experience in quality working with solid oral drug and/or biologics in biotech/pharma.
• Experience with GMP Quality Assurance and Qualification/Validation of processes or test methods.
• Knowledge of electronic QMS systems, familiarity with Veeva QMS is a plus.

Responsibilities

• Assist and support monitoring of technical documents through review workflows using the Quality Management System (Veeva).
• Support data review for internal protocols, reports and other documents.
• Review and approve interim stability reports electronically.
• Cross-check regulatory submission data against source records for discrepancies.
• Develop knowledge of validation requirements, manufacturing processes and analytical testing for Travere products.
• Train and mentor cross-functional team members to enhance performance.
• Support QA with various technical projects as needed.

Skills

Quality Assurance

GMP Compliance

Documentation management

Veeva QMS

Education

Bachelor's degree in life sciences

Tools

Veeva QMS

Job description

Travere Therapeutics in San Diego, CA, is seeking a Senior Specialist, Quality Assurance Technical to support qualification/validation documents and product transfer activities for solid oral dose and biologic programs, ensuring quality and regulatory compliance.

You will work with cross-functional teams, review protocols and reports, manage QMS workflows, and contribute to CAPA, change controls, investigations, and training to develop expertise and advance therapies for rare diseases.