Senior Specialist, Quality Assurance Operations (Temporary)

Vir Biotechnology, Inc. is an immunology company focused on combining cutting-edge technologies to treat and prevent infectious diseases and other serious conditions. Vir has assembled two technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current clinical development pipeline consists of product candidates targeting hepatitis B and hepatitis delta viruses, influenza A and B, human immunodeficiency virus and COVID-19. Vir has several preclinical candidates in its pipeline, including RSV/MPV and HPV.

We believe the success of our colleagues drives the success of our mission. We are committed to creating a company passionate about equality, inclusion, and respect. When everyone feels supported and encouraged to give their best, we will collectively deliver outstanding results. We are proud to have been ranked the fastest-growing company in North America on the 2022 Deloitte Technology Fast 500™.

Vir Biotechnology is seeking an experienced temporary Quality Assurance Operations Senior Specialist. You will support us with initial compliance and ongoing preparation, testing and monitoring of conformance to established quality assurance processes and standards for manufacturing and production. Evaluate internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards. Identify risk and evaluate deficiencies while working with internal departments/teams to remedy them. Facilitate internal training on quality assurance requirements, processes, and procedures. You may perform audits and risk assessments. Reporting to the Director of Quality Assurance in a fully remote capacity, you will work Pacific Standard business hours.

RESPONSIBILITIES AND LEARNING OPPORTUNITIES:

• Perform lot release activities for production including review of batch records, analytical data, certificates of analysis, and other documents (e.g., method validation protocols/reports, product specifications, etc.) as needed for consistency with applicable regulations and for compliance with Vir’s GMP Quality System.
• Review master batch records, labels, and other production documents for compliance, ensuring product quality standards are met.
• Perform review and trending of in-process, release, and stability data for assigned programs under cGMP.
• Identify and escalate quality events including deviations, OOS, temperature excursions, and instances where change control is required.
• Lead external deviations initiated at CxO sites.
• Support and collaborate with Quality Compliance for supplier evaluations, maintenance, qualification, and validation in accordance with Vir’s established requirements and procedures.
• Ensure compliance to Vir’s policies and Standard Operating Procedures.
• Maintain all external effective documents from Vir approval to archival in Vir’s document control system.
• Create and maintain folder structures to facilitate workflows of document reviews and final approved documents.
• Responsible for electronic data entry and electronic routing of documents.
• Proactively evaluate systems to identify improvements with a focus to simplify and standardize processes. May lead and drive improvements as required.
• Collect status updates on document review and approval from cross-functional teams.

 

QUALIFICATIONS AND EXPERIENCE:

• 5+ years of experience in a GMP environment with a background in Quality with an undergraduate degree
• Technical experience and knowledge in cGMP document control
• Early phase experience
• Experience reviewing manufacturing or analytical documents for completeness, accuracy, and adherence to GMP requirements
• Knowledge of ICH/EP/USP guidelines

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Vir’s compensation and benefits are aligned with the current market and commensurate with the person’s experience and qualifications. All full-time employees receive a package that includes: compensation, bonus and equity as well as many other Vir benefits and perks such as: health, dental, vision, life and disability insurance benefits, non-accrual paid time off, company shut down for holidays, commuter benefits, child care reimbursement, education reimbursement, 401K match and lunch for all onsite personnel!

Vir is an equal opportunity employer.  We value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the