Senior Specialist, QA Operations (Temporary)

Vir Biotechnology; San Francisco (CA); Vor Ort; USD 72.000 - 96.000; Vollzeit

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Quality Assurance

GMP compliance

Quality Operations

Documentation management

Cross-functional collaboration

Ausbildung

Bachelor's degree in a scientific discipline

Jobbeschreibung

Senior Specialist, QA Operations (Temporary)

Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple PRO-XTEN ® dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies.

Vir Biotechnology has exclusive rights to the universal PRO-XTEN ® masking platform for oncology and infectious disease. PRO-XTEN ® is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company.

We believe the success of our colleagues drives the success of our mission. We are committed to creating a company where everyone feels supported and encouraged to give their best.

THE OPPORTUNITY

Vir Bio is looking for a Temporary Senior Specialist, Quality Operations (12+ Month Initial Contract) who will support quality oversight activities related to manufacturing, testing, packaging, and labeling operations at Vir Biotechnology and Contract Manufacturing Organizations (CMOs), Contract Testing Laboratories (CTLs), and suppliers. This individual will partner with cross-functional teams to help ensure products are manufactured, tested, and released in compliance with current Good Manufacturing Practices (cGMPs) and applicable regulatory requirements.

You will contribute to quality review and approval activities, support issue management and investigations, and help maintain quality systems that support clinical and commercial products across our development portfolio.

This role is based in our San Francisco, California office with the expectation to be onsite three days per week.

WHAT YOU'LL DO

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

WHO YOU ARE AND WHAT YOU BRING

• Bachelor's degree in a scientific discipline and 5+ years of experience in Quality Assurance, Quality Operations, Manufacturing, or a related GMP-regulated pharmaceutical or biotechnology environment preferred
• Experience supporting GMP manufacturing and testing activities
• Familiarity with quality systems including deviations, CAPAs, change controls, investigations, and document management
• Working knowledge of cGMP regulations and quality principles
• Strong organizational, communication, and collaboration skills
• Experience working with CMOs, CTLs, or suppliers preferred

WHO WE ARE AND WHAT WE OFFER

The expected hourly range for this position is $52.00 to $70.00 per hour. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.

Applicants must currently be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

All employment decisions at Vir Biotechnology are based on legitimate, non-discriminatory business requirements, job duties and individual qualifications. Employment decisions are made without regard to any legally protected characteristics.

This commitment extends to all management practices and decisions, including recruitment and hiring, compensation, appraisal systems, promotions, training and career development programs. Vir Biotechnology also strongly commits to providing employees with a work environment free of unlawful conduct or harassment.

Vir Biotechnology Human Resources leads recruitment and employment for Vir Biotechnology. Unsolicited resumes sent to the company from recruiters do not constitute any type of relationship between the recruiter and Vir Biotechnology and do not obligate us to pay fees should we hire from those resumes. We ask that external recruiters and/or agencies not contact or present candidates directly to our hiring manager or employees.

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