Senior QA Lead for GMP Batch Release & Audits

Vertex Pharmaceuticals; Boston (MA); On-site; USD 84,000 - 90,000; Full time

Job summary

Vertex Pharmaceuticals seeks an Operational Area Senior Quality Specialist to provide QA support for manufacturing, analytical labs and materials management for external programs. You will review batch data and deviations to support product disposition and contribute to batch release processes.

Ideal candidates have GMP experience, strong problem solving and communication skills, and familiarity with TrackWise, Veeva and Oracle.

Qualifications

• Bachelor's degree in a scientific or allied health field.
• Experience providing QA support and oversight of GMP manufacturing operations.
• Experience leading event investigations, root cause analysis and CAPA.
• Experience with Oracle, TrackWise, and Veeva.
• Proficient in Microsoft Office applications.

Responsibilities

• Review executed batch records and provide approvals for quality tasks for externally manufactured products.
• Perform final review of executed batch and critical systems documentation to determine acceptability.
• Ensure presence and acceptability of all required documentation prior to release of product or system.
• Support day-to-day management of the batch release process.
• Assist facility for quality audits and participate in corporate audits and external inspections as needed.
• Communicate proactively with internal and external partners and management.
• Maintain files so documents are readily available and retrievable.
• Assist department with monthly/quarterly Quality System data review metrics and reporting.
• Escalate critical and major findings to Quality management and monitor KPIs with Quality Systems and other GXP areas.

Skills

Communication

Critical Thinking

Problem Solving

Risk-based thinking

MS Office

Education

Bachelor's degree in scientific field

Tools

Oracle

TrackWise

Veeva

Excel

Job description

Vertex Pharmaceuticals seeks an Operational Area Senior Quality Specialist to provide QA support for manufacturing, analytical labs and materials management for external programs. You will review batch data and deviations to support product disposition and contribute to batch release processes.

Ideal candidates have GMP experience, strong problem solving and communication skills, and familiarity with TrackWise, Veeva and Oracle.