Senior Quality Systems Specialist: Packaging & Validation

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

Job summary

Vertex Pharmaceuticals in Boston seeks a Quality Systems Senior Specialist to design and deliver impactful QA metrics and analyses across GxP operations. You will provide actionable insights to quality leadership, supporting proper oversight and prompt trend evaluation.

Ideal candidates will have Finished Goods/Packaging/Labelling experience and a background in Commercial Validation, with independence to review validation docs, batch data, deviations, and change controls.

Qualifications

• Bachelor’s degree in a scientific, engineering, or allied health field and 3+ years of relevant work experience
• Experience with Finished Goods/Packaging/Labelling
• Experience with Commercial Validation (especially packaging validation) preferred
• Strong attention to detail and ability to navigate a fast-paced environment
• Self-motivated, independent, organized, and effective communicator
• Desire to transform lives through innovation in serious diseases

Responsibilities

• Reviews validation documentation
• Performs final review of executed batch records and resolves comments with CMO
• Reviews master batch records for validation and launch
• Verifies documentation before batch release
• Reviews and approves investigations, CAPAs, and change controls for external programs
• Support day-to-day management of lot disposition processes
• Communicates with internal and external stakeholders and maintains retrievable files
• Assists department with monthly/quarterly Quality System metrics and reporting

Skills

Quality Assurance

Regulatory compliance

Attention to detail

Independent worker

Communication

Project management

Education

Bachelor's degree in science/engineering/health

Job description

Vertex Pharmaceuticals in Boston seeks a Quality Systems Senior Specialist to design and deliver impactful QA metrics and analyses across GxP operations. You will provide actionable insights to quality leadership, supporting proper oversight and prompt trend evaluation.

Ideal candidates will have Finished Goods/Packaging/Labelling experience and a background in Commercial Validation, with independence to review validation docs, batch data, deviations, and change controls.