Senior QA Operations Specialist - 12-Month Contract

Vir Biotechnology; 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 to support quality oversight across manufacturing, testing, packaging, and labeling at Vir and CMOs/CTLs.

You will help ensure products are manufactured, tested, and released in compliance with current Good Manufacturing Practices (cGMP) and applicable regulatory requirements. You will contribute to quality review and approval activities, support issue management and investigations, and help maintain quality

Qualifications

• Bachelor's degree in a scientific discipline with 5+ years of QA/QA Ops experience preferred.
• Experience supporting GMP manufacturing and testing activities.
• Familiarity with deviations, CAPAs, change controls, investigations and document management.

Responsibilities

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

Skills

Quality Assurance

GMP compliance

Quality Operations

Documentation management

Cross-functional collaboration

Education

Bachelor's degree in a scientific discipline

Job description

Vir Biotechnology, Inc. is seeking a Temporary Senior Specialist, Quality Operations to support quality oversight across manufacturing, testing, packaging, and labeling at Vir and CMOs/CTLs.

You will help ensure products are manufactured, tested, and released in compliance with current Good Manufacturing Practices (cGMP) and applicable regulatory requirements. You will contribute to quality review and approval activities, support issue management and investigations, and help maintain quality