Senior QA & Validation Specialist – Remote

Travere Therapeutics; Columbus (OH); On-site; USD 95,000 - 124,000; Full time

Benefits offered by this job

Health insurance

Financial wellness

Work-life balance

Well-being programs

Job summary

Travere Therapeutics is seeking 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 to ensure products from contract vendors meet regulatory requirements for clinical studies and commercial operations, focusing on QA processes, data reviews, and QMS workflows. Strong writing and analytical skills required; up to 10% travel.

Qualifications

• Bachelor's degree in life sciences or related field; equivalent combo may be considered.
• 5+ years of quality experience with solid oral drug or biologics.
• Knowledge of GMP QC systems and cGMPs (CFR/ICH).

Responsibilities

• Support documentation review and approval workflows in the QMS (Veeva).
• Review validation protocols/reports for manufacturing and test methods.
• Assist with change controls and investigations with CAPA.
• Review internal/external protocols and interim stability reports.
• Ensure regulatory submission data align with source records.
• Develop knowledge of validation requirements and manufacturing processes.

Skills

Interpersonal skills

Organizational skills

Verbal and written communication

Problem solving

Attention to detail

Cross-functional collaboration

Education

Bachelor's degree in life sciences

Equivalent education/experience

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 biologics programs, ensuring quality and regulatory compliance.

You will work with cross-functional teams to ensure products from contract vendors meet regulatory requirements for clinical studies and commercial operations, focusing on QA processes, data reviews, and QMS workflows. Strong writing and analytical skills required; up to 10% travel.