Senior Remote Quality Assurance Technical Specialist

Travere Therapeutics; Salt Lake City (UT); Hybrid; USD 95,000 - 124,000; Full time

Benefits offered by this job

Premium health

Life insurance

Disability

Retirement plans with employer match

Generous paid time off

Job summary

Travere Therapeutics seeks a Senior Specialist, Quality Assurance Technical to support qualification/validation and product transfer activities for solid oral dose and biologic programs. You will ensure compliance with regulatory requirements, review key documents, and collaborate with cross-functional teams and contract vendors.

Ideal candidates have a life sciences degree and 5+ years in GMP QA with exposure to QMS, CFR/ICH guidelines, and data integrity.

Qualifications

• Bachelor's degree in a life science or related field; Chemistry/Biology/Chemical Engineering preferred.
• 5+ years of quality experience with solid oral drug or biologics in pharma/biotech.
• 5+ years of GMP Quality Assurance, Qualification/Validation, or related QMS.
• Knowledge of electronic QMS systems; understanding of Veeva QMS is a plus.
• Broad knowledge of CFR/ICH and international regulations.

Responsibilities

• Assist qualification/validation documents and product transfer activities.
• Review and approve protocols, reports, and change controls.
• Support data review for internal/external protocols and reports.
• Cross-check regulatory submission data against source records.
• Develop knowledge of validation requirements and manufacturing processes.
• Mentor cross-functional team members and support QA projects.

Skills

Attention to detail

Strong writing

Cross-functional collaboration

Problem-solving

Communication

Education

Bachelor's degree in life science or related field

Tools

Veeva QMS

Job description

Travere Therapeutics seeks a Senior Specialist, Quality Assurance Technical to support qualification/validation and product transfer activities for solid oral dose and biologic programs. You will ensure compliance with regulatory requirements, review key documents, and collaborate with cross-functional teams and contract vendors.

Ideal candidates have a life sciences degree and 5+ years in GMP QA with exposure to QMS, CFR/ICH guidelines, and data integrity.