Senior Quality Assurance Specialist – Biotech (Remote)

Travere Therapeutics; New York (NY); On-site; USD 95,000 - 124,000; Full time

Job summary

Travere Therapeutics in San Diego is seeking a Senior Specialist, Quality Assurance Technical to support qualification/validation documents and product transfer activities for solid oral dose and biologic programs, ensuring quality and compliance with regulatory requirements.

You will work with cross-functional teams to ensure products from contract vendors meet standards for ongoing clinical studies and commercial operations, while developing expertise in validation and QMS processes.

Qualifications

• Bachelor's degree in life science or related field; Chemistry, Biology or Chemical Engineering preferred.
• 5+ years of GMP QA experience with solid oral drugs and/or biologics.
• Experience with Qualification/Validation of processes and/or test methods or other Quality Systems.
• Knowledge of electronic QMS systems; Veeva QMS is a plus.
• Broad knowledge of cGMPs (CFR/ICH) and international regulations.

Responsibilities

• Assist and support monitoring and progression of technical documents through review workflows.
• Support data review for internal/external protocols, reports, and documents.
• Review and approve interim stability reports in the QMS.
• Cross-check regulatory submission data against source records for discrepancies.
• Develop and maintain knowledge of validation requirements and manufacturing/analytical testing.
• Collaborate with cross-functional teams; mentor and develop team members.
• Support QA with various technical projects as needed.

Skills

Interpersonal skills

Organizational skills

Verbal communication

Written communication

Problem solving

Attention to detail

Travel willingness

Team collaboration

Education

Bachelor's in life science

Chemistry/Biology/Engineering preferred

Tools

Veeva QMS

Job description

Travere Therapeutics in San Diego is seeking a Senior Specialist, Quality Assurance Technical to support qualification/validation documents and product transfer activities for solid oral dose and biologic programs, ensuring quality and compliance with regulatory requirements.

You will work with cross-functional teams to ensure products from contract vendors meet standards for ongoing clinical studies and commercial operations, while developing expertise in validation and QMS processes.