About this opportunity
Vir-Biotechnology lists this Senior Specialist, QA Operations (Temporary) opportunity in san francisco, California. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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
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Worksite address
san francisco, CA, 94199, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.