Quality Associate, Batch Record Review and Product Disposition

## Quality Associate, Batch Record Review and Product Disposition Apply locations:
San Diegotime type:
Full time posted on:
Posted 3 Days Agojob requisition :
R-100840

Department:107100 Quality

Location:

San Diego
** 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 Quality Associate supports Quality Operations through the Quality oversight of Manufacturing, Packaging, and Labeling Operations Batch Record Review, Product Disposition, Clinical and Commercial Supplier Management Oversight, quality records management, and GxP Metrics reporting. This position supports completion of Inspection Readiness Action Items and provides compliance support for the quality systems at Travere Therapeutics, Inc. and key suppliers. This position also supports continual process improvement for Quality Management Systems.

** Primary Responsibilities**:
* Support Quality Assurance (QA) Batch Record Review, Product Disposition, and QA Supplier Management including associated quality record management for small molecule, biologics, and device products
* Perform QA Batch Review and Approval of intermediates, drug substance, and final products ensuring all required quality records are complete and compliant prior to product disposition to meet clinical and commercial production timelines
* Collaborate closely with Technical Operations and Clinical Operations Personnel responsible for Manufacturing, Labeling, Packaging, Batch Kitting, and Distribution
* Support QA Supplier Management and Oversight of Contract Manufacturing Organizations (CMOs) starting with Phase 2 Clinical Trials through marketed products, and in all situations where GMP Batches are required
* Manage assigned SOPs revisions and quality records (CAPAs, Deviations, Investigations, Product Complaints, Audit Responses, Change Controls, & Trainings) to ensure timely completion for the organization and associated department(s)
* Participates in supplier meetings, managing production timelines with batch release activities
* Support products for clinical development and commercial production including Oral Drugs, Biologics, and Combination Products
* Provides daily oversight of quality systems records including, CAPAs, Deviations, Investigations, Batch Record Review, and Change Controls
* Support revision of the existing SOP(s) and Work Instructions related to assigned duties to help define a clear and accurate process
** Additional Responsibilities**:
* Support audit program activities for internal, external, mock, and regulatory audits
* Provide quality and compliance oversight and act as a SME for the Quality Systems at Travere including, but not limited to:
* Veeva Quality Vault (Quality Docs and QMS)
* Document Management
* Quality Events (Complaints, Deviations, Audit Findings, Change Controls)
* Quality Actions (Audits, CAPAs, Effectiveness Checks, Investigations, Root Causes)
* Quality Metrics
* Ensure documentation in support of regulatory submissions is uploaded in Quality Docs appropriately
* Oversee the creation, revision, review, and approval of GxP controlled documents (e.g., SOPs, WINs, Forms) and records
* Additional duties assigned as needed
** Education/Experience Requirements:
*** Minimum of 2-3 years of experience in QA batch record review and leading QA oversight of Contract Manufacturing Organizations (CMOs)
* Quality Assurance (QA) experience with Manufacturing, Laboratories, Logistics, CMOs, Distributors, and Warehouses is preferred
** Additional Skills/

Experience:

*** The ideal candidate will embody Travere’s core values:
Patient Inspired, Promoting Community, Courageous, and Stronger Together
* Broad knowledge of cGMPs (CFR/ICH) and applicable international regulations and guidelines
* Preference for candidates familiar and experienced with electronic document management systems and QMS such as Veeva or similar
* Strong professional experience in a similar role within the pharmaceutical industry, providing supplier management support for…