Remote Senior QA Specialist, Validation & Compliance

Travere Therapeutics; Atlanta (GA); Hybrid; USD 95,000 - 124,000; Full time

Job summary

Travere Therapeutics in San Diego (remote-flexible with on-site requirements) is seeking a Senior Specialist, Quality Assurance Technical to support qualification/validation and product transfer activities for solid oral and biologic programs. You will ensure quality and regulatory compliance across cross-functional teams and contract vendors for clinical and commercial use.

The role emphasizes monitoring technical documents within Veeva, change controls, investigations, and CAPA, while

Qualifications

• Bachelor's degree in life science or related field; chemistry/biology/engineering preferred.
• 5+ years of quality experience with solid oral drug and/or biologics in biotech/pharma.
• 5+ years GMP QA, qualification/validation of processes or methods.
• Knowledge of electronic QMS; Veeva QMS is a plus.
• Broad knowledge of cGMPs (CFR/ICH) and international regulations.

Responsibilities

• Assist and support qualification/validation documents, including product transfer activities for solid oral dose and biologics.
• Review and approve technical documents within the Quality Management System (Veeva).
• Support data review for internal/external protocols and reports; assist with interim stability reports.
• Cross-check regulatory submission data against source records; identify discrepancies.
• Develop and maintain knowledge of validation requirements, manufacturing processes and analytical testing for Travere products.
• Mentor and train cross-functional team members; promote professional development.
• Support QA with various technical projects as needed.

Skills

Interpersonal skills

Organizational skills

Verbal communication

Written communication

Attention to detail

Problem solving

Time management

Education

Bachelor's degree in life science or related field

Tools

Veeva QMS

Job description

Travere Therapeutics in San Diego (remote-flexible with on-site requirements) is seeking a Senior Specialist, Quality Assurance Technical to support qualification/validation and product transfer activities for solid oral and biologic programs. You will ensure quality and regulatory compliance across cross-functional teams and contract vendors for clinical and commercial use.

The role emphasizes monitoring technical documents within Veeva, change controls, investigations, and CAPA, while