Shire Jobs

Access to Advanced Health Institute is a Seattle-based nonprofit biotech institute that is undergoing a transformation to lead a global coalition to fight infectious disease and address health disparities and inequities worldwide. We think it's unfair that where a person lives or how much money they make dictates their access to life-changing medicine. We're looking for people who want to join us in increasing accessibility to tools that harness the immune system and allow a healthy life, free of illness and disease, regardless of geography or socio-economic status -- from compassion and collaboration come change. 

We will serve as a center for innovation and collaboration in vaccine and cancer immunotherapy research and development, early-phase GMP manufacturing, and training the next generation of scientists and manufacturing teams to achieve our mission. This is where the high-quality science of an academic research organization and the product-development capabilities of a biotech company meet.

Summary

The QA Associate I/II must perform workforce assessments, provide training to new employees, produce or approve documentation and progress reports, and collaborate with colleagues to ensure that everything is running smoothly and complies with the company's policies and regulations. This position will maintain documents and provide departmental support in a manufacturing setting. Position will depend on experience.

Quality Assurance Associate I range: $49,000 - $61,000 per year. 

Quality Assurance Associate II range: $58,000 - $72,000 per year.

Responsibilities 

• Provide primary support for document control and record management activities for FDA regulated manufacturing operations.
• Support development and revision of SOPs, work instructions and other quality documentation.  
• Review records and documents, for completeness and compliance with FDA quality system requirements.  
• Supports other QA areas including employee training and action tracking, audits, compiling quality metrics, supplier qualification, and validations.  
• Performs other quality assurance activities duties as assigned.  

Requirements

• Bachelor's degree in biological science or other field and 0-4 years of experience in a regulated drug product manufacturing environment. 
• Solid written and oral communication skills; ability to communicate effectively.   
• Proficiency in MS Office (Word, Excel) and record management.    
• Ability to work accurately with close attention to detail.   
• Ability to work independently and as part of a team; ability to motivate self.   
• Possess a work ethic that includes integrity, accountability, accuracy, neatness, and punctuality.   
• Ability to take initiative and prioritize tasks; good time-management and problem-solving skills.    
• Flexibility in performing multiple tasks.   

Benefits

We offer a comprehensive compensation plan which includes:

Medical, Dental, Vision?