Remote Senior QA & Validation Specialist

Travere Therapeutics; Oklahoma City (OK); Hybrid; USD 95,000 - 124,000; Full time

Job summary

Travere Therapeutics in San Diego, CA, seeks a Senior Specialist, Quality Assurance Technical to support qualification/validation documents for solid oral dose and biologics programs, ensuring quality and regulatory compliance.

You will work with cross-functional teams, support change controls, data reviews, interim stability reports, and QA on process validation and testing methods, while traveling up to 10% domestically and internationally.

Qualifications

• Bachelor's degree in life science or related field; chemistry, biology, or chemical engineering preferred.
• 5+ years in quality with solid oral drug or biologics; biotech/pharma experience.
• 5+ years in GMP QA, qualification/validation of processes or test methods; QA systems.

Responsibilities

• Assist with monitoring and progression of technical documents through review workflows in the Quality Management System (Veeva).
• Support validation protocols and reports for manufacturing processes and test methods.
• Handle change controls related to supplier changes and investigations with CAPA.
• Review data for internal and external protocols, reports, and other documents.
• Assist with interim stability report reviews and electronic approvals.
• Cross-check regulatory submission data against source records for discrepancies.
• Develop knowledge of validation requirements, manufacturing processes, and analytical testing.
• Mentor cross-functional team members and support various QA projects.

Skills

Quality Assurance

GMP Compliance

Regulatory Knowledge

Documentation Skills

Cross-functional Collaboration

Education

Bachelor's degree in life sciences

Tools

Veeva QMS

QMS Systems

Job description

Travere Therapeutics in San Diego, CA, seeks a Senior Specialist, Quality Assurance Technical to support qualification/validation documents for solid oral dose and biologics programs, ensuring quality and regulatory compliance.

You will work with cross-functional teams, support change controls, data reviews, interim stability reports, and QA on process validation and testing methods, while traveling up to 10% domestically and internationally.