Quality Associate, Batch Record Review and Product Disposition

Scorpion Therapeutics; United States; On-site; USD 85,000 - 105,000; Full time

Benefits offered by this job

Premium health insurance

Life insurance

Retirement with match

Generous paid time off

Job summary

Scorpion Therapeutics is seeking a Quality Associate to support Quality Operations, overseeing batch record reviews, product disposition, and supplier management for GMP batches across multiple product types. The role collaborates with Technical Operations and Clinical Operations to ensure compliant manufacturing, labeling, packaging, and distribution.

Responsibilities include maintaining quality system records, supporting audits, and acting as an SME for quality systems.

Qualifications

• 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.

Responsibilities

• Support QA batch record review, product disposition, and QA supplier management.
• Perform QA batch review/approval for intermediates, drug substance, and final products prior to disposition.
• 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.

Skills

cGMP knowledge

Cross-functional communication

Documentation management

Regulatory inspections

Quality metrics

Education

Bachelor's degree in life sciences

Tools

Veeva Quality Vault

QualityDocs

Job description

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).