Quality Sr. Scientist (Quality Assurance)

In this role you will oversee GMP laboratory testing and assay-related validation activities to ensure product quality and regulatory compliance. You will support vaccine manufacturing QA, lead project initiatives, and coach junior staff while driving continuous improvements in quality systems. You'll work with cross-functional teams to interpret data, authorize documentation, and ensure timely delivery of quality outputs. This position offers an opportunity to shape QA processes in a biotech/pharma environment within a large IT-enabled staffing context.

• Quality review/oversight of GMP documentation for vaccine manufacturing to ensure regulatory compliance
• Perform testing of clinical/commercial product, raw materials, and validation samples
• Design projects/studies with minimal supervision and present findings
• Analyze results and make decisions on accuracy and compliance
• Authorize/approve release of documentation/equipment/processes
• Suggest improvements to Quality systems to enhance facility compliance
• Plan and lead projects to ensure timely completion
• Provide guidance/coaching to junior colleagues

• 5-8 years in manufacturing, quality or engineering in biotech/pharma
• BS/BA degree in Science or related field (minimum)
• GMP experience
• quality-focused background with ability to lead
• strong documentation and decision-making skills

• independence in project design
• investigative orientation
• ability to present findings clearly
• GMP
• assay validation
• quality assurance