Senior Quality Assurance Specialist — Remote

Travere Therapeutics; Denver (CO); On-site; USD 95,000 - 124,000; Full time

Benefits offered by this job

Premium health

Retirement plan with employer match

Paid time off

Job summary

Travere Therapeutics is seeking a Senior Specialist, Quality Assurance Technical, to support qualification/validation documents for solid oral dose and biologic programs. The role ensures quality and regulatory compliance through cross-functional teamwork and QMS workflows.

The successful candidate will review protocols, reports, and stability data, with exposure to Veeva QMS, CAPA, and investigations. Travel up to 10% is required, and onsite work in San Diego is expected.

Qualifications

• Bachelor's degree in life sciences or related field required.
• 5+ years of QA experience in biotech/pharma (solid oral dose or biologics).
• Knowledge of cGMPs CFR/ICH and related international regulations.
• Experience with electronic QMS systems is a plus.

Responsibilities

• Assist with qualification/validation documents and product transfer activities.
• Support monitoring of documents through review workflows in QMS (Veeva).
• Review interim stability reports and regulatory submission data for discrepancies.
• Develop knowledge of validation requirements and manufacturing processes.
• Mentor team members and support cross-functional projects.

Skills

Quality Assurance

Attention to detail

Communication skills

Cross-functional collaboration

Education

Bachelor's degree in life sciences

Tools

Veeva QMS

Job description

Travere Therapeutics is seeking a Senior Specialist, Quality Assurance Technical, to support qualification/validation documents for solid oral dose and biologic programs. The role ensures quality and regulatory compliance through cross-functional teamwork and QMS workflows.

The successful candidate will review protocols, reports, and stability data, with exposure to Veeva QMS, CAPA, and investigations. Travel up to 10% is required, and onsite work in San Diego is expected.