Senior Quality Assurance Specialist - Remote (Biotech)

Travere Therapeutics; Des Moines (IA); On-site; USD 95,000 - 124,000; Full time

Benefits offered by this job

Health insurance

Retirement plans with company match

Paid time off

Job summary

Travere Therapeutics, Inc. is seeking a Senior Specialist, Quality Assurance Technical to support the Quality team with qualification/validation documents and product transfer activities for solid oral dose and biologic programs.

The role ensures product quality and regulatory compliance for Travere's therapies used in clinical studies and commercial operations. You will collaborate with cross-functional teams, manage review workflows in the QMS (Veeva), and contribute to investigations, CAPA,

Qualifications

• Bachelor’s degree in life sciences or related field; Chemistry/Biology/Chemical Engineering preferred.
• 5+ years of QA experience with solid oral drugs and/or biologics in biotech/pharma.
• 5+ years in GMP QA, qualification/validation of processes and/or test methods.
• Knowledge of electronic QMS systems; Veeva QMS is a plus.
• Broad knowledge of cGMPs (CFR/ICH) and international regulations.

Responsibilities

• Assist and support monitoring of technical documents through QMS workflows.
• Support validation protocols and reports for manufacturing and testing.
• Review interim stability reports and ensure data accuracy for regulatory submissions.
• Cross-check data against approved source records to identify discrepancies.
• Develop and maintain knowledge of validation requirements and processes.
• Collaborate cross-functionally; mentor team members and share knowledge.
• Support QA with various technical projects as needed.

Skills

Quality Assurance

Veeva QMS

cGMPs

Documentation

Cross-functional collaboration

Technical writing

Travel readiness

Education

Bachelor's degree in life sciences

Tools

Electronic QMS

Job description

Travere Therapeutics, Inc. is seeking a Senior Specialist, Quality Assurance Technical to support the Quality team with qualification/validation documents and product transfer activities for solid oral dose and biologic programs.

The role ensures product quality and regulatory compliance for Travere's therapies used in clinical studies and commercial operations. You will collaborate with cross-functional teams, manage review workflows in the QMS (Veeva), and contribute to investigations, CAPA,