Senior QA Operations Specialist - GMP (Temp)

Virbiotechnologyinc; San Francisco (CA); On-site; USD 72,000 - 96,000; Full time

Job summary

Vir Biotechnology, Inc. is seeking a Temporary Senior Specialist, Quality Operations (12+ Month Initial Contract) to support quality oversight across manufacturing, testing, packaging, and labeling activities at Vir and CMOs/CTLs.

The role partners with cross-functional teams to ensure products meet cGMP and regulatory requirements, with on-site presence in San Francisco three days per week. The candidate will review quality records, support investigations and issue management, and maintain

Qualifications

• Bachelor's degree in a scientific discipline; 5+ years in Quality Assurance/Quality Operations or GMP-regulated environment preferred.
• Experience supporting GMP manufacturing and testing activities.
• Familiarity with quality systems: deviations, CAPAs, change controls, investigations, document management.

Responsibilities

• Support quality oversight of manufacturing, testing, packaging, and labeling activities performed by CMOs/CTLs/suppliers.
• Review quality records: deviations, CAPAs, change controls, investigations, SOPs.
• Review manufacturing/testing documentation, batch records, and release documentation.
• Support batch disposition and release activities.
• Review validation protocols/reports: process, method, cleaning validation.
• Collaborate with cross-functional teams to address quality issues.
• Assist supplier quality management and Quality Agreement maintenance.
• Support internal/supplier audits and regulatory inspection readiness.
• Escalate quality issues and compliance risks to management.
• Contribute to continuous improvement initiatives within Quality.

Skills

Quality Assurance

Quality Operations

GMP Regulations

Documentation Management

CAPA Management

Supplier Collaboration

Education

Bachelor's degree in a scientific discipline

Job description

Vir Biotechnology, Inc. is seeking a Temporary Senior Specialist, Quality Operations (12+ Month Initial Contract) to support quality oversight across manufacturing, testing, packaging, and labeling activities at Vir and CMOs/CTLs.

The role partners with cross-functional teams to ensure products meet cGMP and regulatory requirements, with on-site presence in San Francisco three days per week. The candidate will review quality records, support investigations and issue management, and maintain