Senior Quality Specialist, Technical

Department:107100 Quality

Location:

San Diego, USA
- Remote Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease.

At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients. Our work is rewarding – both professionally and personally – because we are making a difference. We are passionate about what we do.

We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission – to identify, develop and deliver life-changing therapies to people living with rare disease. We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community.

At Travere Therapeutics, we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients .

Position Summary:

The Senior Specialist, Quality Assurance Technical, will assist the Quality team with qualification/validation documents including product transfer activities supporting solid oral dose and biologic product programs to ensure quality and compliance of the Travere product(s) to the Regulatory requirements and applicable guidance. This role works with the cross functional Travere team to ensure safe and effective products are produced by Travere’s contract vendors for use in ongoing clinical studies and through commercial operations.

Responsibilities :

Assist and support the monitoring and progression of technical documents through structured review and approval workflows working with cross functional teams and utilizing the Quality Management System (Veeva}:

Protocols and Reports for validation of:

Manufacturing Processes Test Methods Change Controls related to supplier changes

Manufacturing and Laboratory Investigations Associated CAPA and Effectiveness Checks Support data review for internal and external protocols, reports, and other document types where needed.

Assist with the review and electronic QMS approval of interim stability reports.

Cross check regulatory submission data against approved source records to identify any discrepancies.

Develop and maintain knowledge of validation requirements, manufacturing processes and analytical testing applicable to Travere products.

Maintains and proactively develops technical skill sets while working with cross function team members through knowledge sharing, training, coaching, and mentoring with the goal of professional development and enhanced job performance.

Support QA with various technical projects as needed. Education/Experience Requirements:

Bachelor’s degree in a life science or related field of study. A relevant technical or scientific field, Chemistry, Biology, or Chemical Engineering is preferred. Equivalent combination of education and applicable job experience may be considered.
5+ years of experience in quality working with solid oral drug and/or biologics in the biotechnology or pharmaceutical industry.
5+ years of experience in GMP Quality Assurance, Qualification/Validation of Process and/or Test Methods or other applicable Quality Systems.

Knowledge of electronic QMS systems, understanding of Veeva QMS is a plus.

Broad knowledge of cGMPs (CFR/ICH) and applicable international regulations and guidelines.

Additional Skills/

Experience:

The ideal candidate will embody Travere’s core values:
Courage, Community Spirit, Patient Focus and Teamwork.

Driven, intelligent, passionate about making a difference for…