Senior QA Specialist - Remote Validation & Compliance

Travere Therapeutics; Kansas City (MO); Hybrid; USD 95,000 - 124,000; Full time

Job summary

Travere Therapeutics, Inc. 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 across clinical and commercial stages.

The role collaborates with cross-functional teams, leverages the Veeva QMS, and contributes to investigations, change controls, data review, and training, with travel up to 10% and a focus on accurate, timely

Qualifications

• Bachelor's degree in a life science or related field required.
• 5+ years of quality experience in biotech/pharma.
• Experience with GMP Quality Assurance and validation.
• Familiarity with electronic QMS systems; Veeva QMS a plus.
• Strong written and verbal communication and cross-functional collaboration.

Responsibilities

• Assist qualification/validation activities for manufacturing processes and test methods.
• Manage change controls related to supplier changes and CAPA activities.
• Review internal/external protocols, reports, and stability documents.
• Support data reviews and QMS approvals of interim stability reports.
• Ensure regulatory data is accurate and traceable to source records.
• Help develop validation requirements and maintain expertise across Travere products.

Skills

Quality Assurance

cGMP knowledge

Documentation

Veeva QMS

Cross-functional teamwork

Education

Bachelor's degree in a life science or related field

Tools

Veeva QMS

Job description

Travere Therapeutics, Inc. 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 across clinical and commercial stages.

The role collaborates with cross-functional teams, leverages the Veeva QMS, and contributes to investigations, change controls, data review, and training, with travel up to 10% and a focus on accurate, timely