Senior QA Specialist - Validation & Compliance (Remote)

Travere Therapeutics

Wichita (KS)

On-site

USD 95,000 - 124,000

Full time

9 days ago

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Job summary

Travere Therapeutics in San Diego invites a Senior Specialist, Quality Assurance Technical, to support solid oral dose and biologic programs. You will ensure quality/compliance with regulatory requirements and collaborate with contract vendors for studies and commercial operations.

The role emphasizes qualification/validation documents, cross-functional teamwork, and strong data integrity, with travel up to 10% domestically and internationally; on-site collaboration in San Diego is expected and

Qualifications

Bachelor's degree in a life science or related field (Chemistry, Biology, or Chemical Engineering) preferred.
5+ years of quality experience in solid oral drug and/or biologics within biotech/pharma.
Strong knowledge of cGMPs (CFR/ICH) and international regulations; Veeva QMS familiarity is a plus.

Responsibilities

Assist qualification/validation documents and product transfer activities.
Review and approve stability reports and data to support regulatory compliance.
Cross-check regulatory submission data with source records for discrepancies.
Develop and maintain knowledge of validation requirements and manufacturing processes.
Mentor and train teammates; support cross-functional collaboration on QA projects.
Travel up to 10% domestically and internationally as needed.