Quality Associate, Batch Record Review and Product Disposition
Travere Therapeutics
August 24, 2026
On-site
San Diego Metropolitan Area
Operations
Position Summary:
The Quality Associate supports Quality Operations through quality oversight of Manufacturing, Packaging, and Labeling batch record review, product disposition, supplier management oversight, quality records management, and GxP metrics reporting. Supports inspection readiness action items, compliance for Travere and key suppliers, and continual process improvement for Quality Management Systems.
Primary Responsibilities:
- Support QA batch record review, product disposition, and QA supplier management (including quality record management for small molecule, biologics, and device products)
- Perform QA batch review/approval for intermediates, drug substance, and final products prior to disposition; ensure required records are complete and compliant
- Collaborate with Technical Operations and Clinical Operations on manufacturing, labeling, packaging, batch kitting, and distribution
- Support QA supplier management and oversight of CMOs from Phase 2 through marketed products for GMP batches
- Manage SOP revisions and quality records (CAPAs, deviations, investigations, product complaints, audit responses, change controls, trainings)
- Participate in supplier meetings and manage production timelines with batch release activities
- Provide daily oversight of quality system records (CAPAs, deviations, investigations, batch record review, change controls)
- Support revision of SOPs and work instructions
Additional Responsibilities:
- Support internal/external/mock/regulatory audit activities
- Act as SME for quality systems (e.g., Veeva Quality Vault, document management, quality events/actions, quality metrics)
- Ensure regulatory submission documentation is uploaded in QualityDocs; oversee GxP controlled document creation/revision/approval
Education/Experience Requirements:
- 2–3+ years’ experience in QA batch record review and leading QA oversight of CMOs
- Preferred: QA experience with manufacturing, laboratories, logistics, CMOs, distributors, warehouses
Additional Skills/Experience (Required/Preferred):
- Broad cGMP (CFR/ICH) knowledge and applicable international regulations
- Preference for electronic document/QMS tools (e.g., Veeva)
- Strong communication, organization, prioritization, and multitasking in a cross-functional environment
- Experience with regulatory inspections; ability to work onsite in San Diego (not 100% remote)
- Travel 10–20% domestically/internationally (preferred/required as stated)
Benefits/Compensation:
- Target base pay range: $85,000–$105,000.
- Benefits include premium health, life insurance, disability, retirement with match, and generous paid time off (plus work-life/well-being offerings).
Application Instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected.
The Quality Associate supports Quality Operations through quality oversight of Manufacturing, Packaging, and Labeling batch record review, product disposition, supplier management oversight, quality records management, and GxP metrics reporting. Supports inspection readiness action items, compliance for Travere and key suppliers, and continual process improvement for Quality Management Systems.
Primary Responsibilities:
- Support QA batch record review, product disposition, and QA supplier management (including quality record management for small molecule, biologics, and device products)
- Perform QA batch review/approval for intermediates, drug substance, and final products prior to disposition; ensure required records are complete and compliant
- Collaborate with Technical Operations and Clinical Operations on manufacturing, labeling, packaging, batch kitting, and distribution
- Support QA supplier management and oversight of CMOs from Phase 2 through marketed products for GMP batches
- Manage SOP revisions and quality records (CAPAs, deviations, investigations, product complaints, audit responses, change controls, trainings)
- Participate in supplier meetings and manage production timelines with batch release activities
- Provide daily oversight of quality system records (CAPAs, deviations, investigations, batch record review, change controls)
- Support revision of SOPs and work instructions
Additional Responsibilities:
- Support internal/external/mock/regulatory audit activities
- Act as SME for quality systems (e.g., Veeva Quality Vault, document management, quality events/actions, quality metrics)
- Ensure regulatory submission documentation is uploaded in QualityDocs; oversee GxP controlled document creation/revision/approval
Education/Experience Requirements:
- 2–3+ years’ experience in QA batch record review and leading QA oversight of CMOs
- Preferred: QA experience with manufacturing, laboratories, logistics, CMOs, distributors, warehouses
Additional Skills/Experience (Required/Preferred):
- Broad cGMP (CFR/ICH) knowledge and applicable international regulations
- Preference for electronic document/QMS tools (e.g., Veeva)
- Strong communication, organization, prioritization, and multitasking in a cross-functional environment
- Experience with regulatory inspections; ability to work onsite in San Diego (not 100% remote)
- Travel 10–20% domestically/internationally (preferred/required as stated)
Benefits/Compensation:
- Target base pay range: $85,000–$105,000.
- Benefits include premium health, life insurance, disability, retirement with match, and generous paid time off (plus work-life/well-being offerings).
Application Instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected.