Senior Quality Systems Specialist – Packaging & Validation

Vertex Pharmaceuticals LLC; Boston (MA); On-site; USD 76,000 - 90,000; Full time

Job summary

Vertex Pharmaceuticals LLC is seeking a Quality Systems Senior Specialist to support design and delivery of metrics across GxP operations and to provide actionable insights to quality leadership for oversight and trend evaluation.

The role involves reviewing validation documentation, batch data, deviations, change controls, and other QA documentation to support validation and product disposition, with emphasis on finished goods, artwork management, and packaging validation.

Qualifications

• Bachelor’s degree in a scientific, engineering, or allied health field; 3+ years of relevant work experience
• Experience with Finished Goods/Packaging/Labelling
• Experience with Commercial Validation, especially packaging validation
• Strong attention to detail; self-motivated and organized
• Effective communicator and able to navigate a fast-paced environment

Responsibilities

• Review validation documentation and ensure quality system compliance
• Perform final review of executed batch records and resolve comments with CMO
• Review master batch records for validation and launch; ensure changes are documented
• Confirm presence and acceptability of required documents prior to batch release
• Review investigations, CAPAs, and change controls for external programs
• Support monthly/quarterly quality system metric reporting

Skills

Quality systems

Validation documentation

Batch records

CAPA management

Education

Bachelor's degree in science/engineering/health

Job description

Vertex Pharmaceuticals LLC is seeking a Quality Systems Senior Specialist to support design and delivery of metrics across GxP operations and to provide actionable insights to quality leadership for oversight and trend evaluation.

The role involves reviewing validation documentation, batch data, deviations, change controls, and other QA documentation to support validation and product disposition, with emphasis on finished goods, artwork management, and packaging validation.