Quality Assurance Specialist II, GMP Manufacturing - Seattle Children's

Responsibilities: Assist members of the Seattle Children's Therapeutics with development, implementation, and maintenance of quality assurance systems and activities. Perform internal audits, assist with manufacturing and QC site audits, provide document control functions, conduct failure investigations, assist with CAPAs, and coordinate the development and review of Standard Operating Procedures and Production Batch Records. Requirements: Required Education/Experience: + BA/BS degree in biological sciences or health related field or equivalent. + Minimum two (2) years academic, biotechnological, or pharmaceutical industry hands on QA experience in a GMP biologics manufacturing environment. Required Credentials: + N/A. Preferred: + Knowledge of the regulatory (cGMP, GLP, CBER, etc) and technical (production and testing methodologies of cell-based products. + Experience with CAR T manufacturing and testing procedures. Min to Max Hourly Salary: $36.75 - $55.12 /hr Min to Max Annual Salary: $76,440.00 - $114,649.60 /yr Salary Information: This compensation range was calculated based on full-time employment (2080 hours worked per calendar year). Offers are determined by multiple factors including equity, skills, experience, and expertise, and may vary within the range provided. Disclaimer for Out of State Applicants: This compensation range is specific to Seattle, positions located outside of Seattle may be compensated differently depending on various factors **.** Benefits Information: Seattle Children's offers a generous benefit package, including medical, dental, and vision plans, 403(b), life insurance, paid time off, tuition reimbursement, and more. Click here (https://www.seattlechildrens.org/careers/benefits/) for more information. About Us: **Hope. Care. Cure. These three simple words capture what we do at Seattle Children's - to help every child live the healthiest and most fulfilling life possible. Are you ready to engage with a mission-driven organization that is life-changing to many, and touches the hearts of all? #HOPECARECURE** As one of the nation's top five pediatric research centers, Seattle Children's Research Institute is dedicated to providing hope, care, and cures to help every child live the healthiest and most fulfilling life possible. Our investigators are involved in hundreds of projects that cover every phase of research, from studying how diseases work to improving investigational therapies. They have pioneered groundbreaking cystic fibrosis treatments and cutting-edge cancer therapies that help a child's immune system defeat cancer, and made other major contributions to pediatric medicine. Researchers work in close collaboration with one another, their colleagues at partner institutions including the University of Washington (http://www.washington.edu/) and Fred Hutch (http://www.fredhutch.org/) and our healthcare providers at Seattle Children's Hospital, one of U.S. News & World Report's (https://www.seattlechildrens.org/about/us-news-world-report-rankings/) top children's hospitals. This collaboration is one of our key strengths, allowing our faculty to draw on a variety of disciplines and techniques as they pursue solutions to some of medicine's most complex problems. We are committed to not only treating disease but to eliminating it. Help us achieve our vision of being a worldwide leader in pediatric research aimed to improve the health and well-being of children. If you are interested in a challenging career aimed at groundbreaking research, Seattle Children's Research Institute is the place for you. Our Commitment to Diversity: _Our community welcomes diverse experiences, backgrounds, and thoughts as this is what drives our spirit of inquiry and allows us to better connect with our increasingly diverse patients and families. Our organization recruits, employs, trains, compensates, and promotes without regard to race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics._ _The people who work at Seattle Children's are members of a community that seeks to respect and celebrate all the qualities that make each of us unique. Each of us is empowered to be ourselves within this community, which cultivates and promotes equity, diversity, and inclusion at all levels._ _Seattle Children's is proud to be an Equal Opportunity Workplace and Affirmative Action Employer._