QA Operations, Senior Specialist

Join our team of pioneers!

Based in Cambridge, MA and Gaithersburg, MD. We are committed to improving the health of people worldwide with our fundamental research and our work in the area of development of immunotherapies utilizing the full potential of the immune system to fight cancer, infectious diseases and other serious diseases. We believe in scientific rigor, innovation and passion as driving forces. BioNTech was founded by scientists and physicians to translate science into survival by combining fundamental research and operational excellence.

With decades of deep immunology expertise and experience in developing and optimizing mRNA as part of its broad suite of novel technologies, the company is working with the global community to defeat life-threatening and serious diseases such as cancer, COVID-19, malaria and tuberculosis. The first ever approved mRNA vaccine was created in the labs of BioNTech in Mainz, Germany. A fully integrated immunotherapy powerhouse. We remain focused on bringing our broad pipeline of next-generation immunotherapies and vaccines to people around the world to address cancer, infectious diseases, as well as a growing list of other medical conditions. To accomplish this, we continue to be deeply rooted in science and academic research while also having built a fully integrated, global immunotherapy company with cGMP and GMP manufacturing facilities anchored around deep expertise in immunology and complemented by an expanding set of capabilities.

 

 

QA Operations, Senior Specialist 

 

Responsibilities (include but are not limited to):

 

• Provide Quality Assurance support resolving raw material, in-process material and/or product, final product, environmental, analytical, facility and equipment manufacturing issues
• Provide Quality Assurance input and oversight in resolving tech transfer, manufacturing and warehouse operations-related issues 
• Provide on-the-floor QA support in GMP cleanroom and laboratory environments and support to ensure compliance to GMP regulations throughout those areas 
• Perform quality walk-throughs and process observations 
• Disposition incoming materials 
• Perform receipt and disposition of incoming patient apheresis material  
• Perform issuance verification of production documents and labels, to meet production schedule
• Review batch-related documentation, test methods and EM data
• Perform batch closure and drug product disposition activities
• Ensure products are manufactured in compliance with regulatory and GMP guidelines   
• Oversee the packaging and shipping processes for drug product
• Support deviation system and ensure proper investigation and root cause analysis are performed and corrective actions implemented
• Support the CAPA system and ensure timely closure and effectiveness of investigations and corrective and preventive actions
• Conduct effective root cause analysis and implement corrective action and preventive action
• Support quality assessments of internal operations to analyze compliance and assess risk
• Review and approve proposed changes to systems, procedures, and methods
• Review and approve investigations and change controls in compliance with SOPs and timelines
• Support audits
• Support tracking of site quality metrics to management
• Generate, revise and/or approve standard opera