Vir is a clinical-stage immunology company with a compelling mission: "A World Without Infectious Disease". We are focused on combining immunologic insights with cutting-edge technologies. We have assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Our current development pipeline consists of product candidates targeting COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus.
We believe the success of our colleagues drives the success of our Mission. We have an ongoing commitment to creating a company passionate about equality, inclusion, and respect. When everyone feels supported and encouraged to give at their best, we will collectively deliver outstanding results.
Vir Biotechnology is seeking an experienced Senior Specialist, QA Operations to Support the mAbs quality team. Assists and supports the manufacturing and analysis of mAbs at CMOs and CTLs and labeling of clinical and commercial supplies in compliance with cGMP and VIR requirements. Assess, review, and approve Deviations, Changes, excursions, and risk in accordance with internal and external safety, quality, and regulatory standards.
RESPONSIBILITIES AND LEARNING OPPORTUNITIES:
- Performs lot release activities for product including, but not limited to, 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.
- Reviews and approves master batch records, labels, and other production documents, as needed in compliance with GMP Regulations, Regulatory filings, and quality agreements.
- Identifies and escalates quality events including deviations, OOS, temperature excursions, investigations, and change control in accordance with Vir's established process.
- Review and approve Changes, deviations, and investigations at CxOs.
- Supports and collaborates with Quality Compliance for supplier evaluations, maintenance, & qualification in accordance with Vir's established requirements and procedures.
- Ensures compliance to Vir's policies and Standard Operating Procedures.
- Maintains all external effective documents from Vir approval to archival in Vir's document control system.
- Proactively evaluates systems and processes to identify improvements with a focus to simplify and standardize processes. May lead and drive improvements as required.
QUALIFICATIONS AND EXPERIENCE:
- 5+ years of experience in a GMP environment with a background in Quality assurance, with a bachelor degree in a related scientific discipline.
- Technical experience and knowledge in cGMP and GLP.
- Experience reviewing manufacturing and analytical documents for completeness, accuracy, and adherence to GMP requirements.
- Experience with packaging and labeling / repacking activities.
- QC experience is a plus.
- Knowledge of ICH/EP/USP guidelines.
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, one Friday a month paid-time off, company shut down for holidays, commuter benefits, child care reimbursement, education reimbursement, 401K match and lunch for all lab essential 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 job application or interview process, to perform critical job functions, and to receive other benefits and privileges of employment. Please contact Human Resources to request accommodation.
Vir Human Resources leads recruitment and employment for Vir. Unsolicited resumes sent to Vir from recruiters do not constitute any type of relationship between the recruiter and Vir and do not obligate Vir 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.