Quality Associate, Batch Record Review and Product Disposition
Travere Therapeutics
8 days ago
Remote friendly (San Diego Metropolitan Area)
United States
Operations
Position Summary
- The Quality Associate supports Quality Operations through Quality oversight of Manufacturing, Packaging, and Labeling batch record review, product disposition, clinical/commercial supplier management oversight, quality records management, and GxP metrics reporting.
Primary Responsibilities
- Support QA batch record review, product disposition, and QA supplier management; manage quality records for small molecule, biologics, and device products.
- Perform QA batch review/approval of intermediates, drug substance, and final products to ensure complete/compliant records prior to product disposition.
- Collaborate with Technical and Clinical Operations for Manufacturing, Labeling, Packaging, Batch Kitting, and Distribution.
- Support QA supplier management/oversight of CMOs from Phase 2 through marketed products (and all GMP batch situations).
- Manage SOP revisions and quality records (CAPAs, deviations, investigations, product complaints, audit responses, change controls, trainings).
- Provide daily oversight of quality system records and support revisions to SOPs/Work Instructions.
Additional Responsibilities
- Support internal/external/mock/regulatory audits.
- Serve as SME for Quality Systems (Veeva Quality Vault/QualityDocs & QMS, document management, quality events/actions, quality metrics) and ensure regulatory submission documentation is uploaded.
Education/Experience Requirements
- 2–3+ years in QA batch record review and leading QA oversight of CMOs.
- QA experience with manufacturing, labs, logistics, CMOs, distributors, and warehouses (preferred).
Additional Skills/Experience (Required/Preferred)
- cGMPs (CFR/ICH), international regulations; strong communication, organization, multitasking, problem-solving, attention to detail.
- Familiar with electronic document/QMS tools (e.g., Veeva).
- Prefer (but not required) prior line management; regulatory inspection experience.
- Onsite in San Diego (not 100% remote); travel 10–20%.
Benefits/Compensation (if applicable)
- Benefits: premium health, wellness/employee support, life insurance, disability, retirement match, generous paid time off.
- Target base pay range: $85,000–$105,000.
Application Instructions
- Applications accepted 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, clinical/commercial supplier management oversight, quality records management, and GxP metrics reporting.
Primary Responsibilities
- Support QA batch record review, product disposition, and QA supplier management; manage quality records for small molecule, biologics, and device products.
- Perform QA batch review/approval of intermediates, drug substance, and final products to ensure complete/compliant records prior to product disposition.
- Collaborate with Technical and Clinical Operations for Manufacturing, Labeling, Packaging, Batch Kitting, and Distribution.
- Support QA supplier management/oversight of CMOs from Phase 2 through marketed products (and all GMP batch situations).
- Manage SOP revisions and quality records (CAPAs, deviations, investigations, product complaints, audit responses, change controls, trainings).
- Provide daily oversight of quality system records and support revisions to SOPs/Work Instructions.
Additional Responsibilities
- Support internal/external/mock/regulatory audits.
- Serve as SME for Quality Systems (Veeva Quality Vault/QualityDocs & QMS, document management, quality events/actions, quality metrics) and ensure regulatory submission documentation is uploaded.
Education/Experience Requirements
- 2–3+ years in QA batch record review and leading QA oversight of CMOs.
- QA experience with manufacturing, labs, logistics, CMOs, distributors, and warehouses (preferred).
Additional Skills/Experience (Required/Preferred)
- cGMPs (CFR/ICH), international regulations; strong communication, organization, multitasking, problem-solving, attention to detail.
- Familiar with electronic document/QMS tools (e.g., Veeva).
- Prefer (but not required) prior line management; regulatory inspection experience.
- Onsite in San Diego (not 100% remote); travel 10–20%.
Benefits/Compensation (if applicable)
- Benefits: premium health, wellness/employee support, life insurance, disability, retirement match, generous paid time off.
- Target base pay range: $85,000–$105,000.
Application Instructions
- Applications accepted on an ongoing basis until a candidate is selected.