Quality Assurance Specialist II, GMP Clinical Manufacturing

Job ID 2020-35879
Area of Interest
Qual Imp/Util Review/Case Mgmt
Location Name
Olive Lab at MPW
FTE/Hours per pay period
1.0 FTE (80 hours per bi-weekly pay periods)
Work Status
Core Svcs Ops - GMP
Day Shift
Primary Location : City
Primary Location : State/Province

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 and Fred Hutch and our healthcare providers at Seattle Children's Hospital, one of U.S. News & World Report’s 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.


Join our incredible Therapeutic Cell Production Core (TCPC ) team and have an amazing impact on the Seattle Children's mission! The GMP Quality Assurance Specialist will work in one of only a very few pediatric-dedicated facilities in the U.S. that meet the FDA's strict Good Manufacturing Practice (GMP) requirements for manufacturing therapeutic cell products. You’ll assist with development, implementation, and maintenance of quality assurance systems and activities for a facility operating cutting edge scientific procedures and techniques in a highly regulated environment (GMP compliant) for clinical research trials. You will assist with members of the TCPC team to 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. You may also assist in preparation of reports and regulatory submissions. Want to know more about the TCPC team? Check out their webpage!



Seattle Children's Employer Highlights:
- Leader in Pediatric Care: Because of our people, Seattle Children’s is recognized as a leading teaching, research and specialty care center at the forefront of pediatric care.
- Competitive Benefits: We support a healthy work–life balance. Our benefits include employee care, paid time off, health insurance and retirement savings.
- Transportation Discounts: Company bike program, on-site zip cars, unlimited ORCA transit pass, daily commute bonus provided to staff who us alternate methods of travel to/from work, company vanpools.
- Diversity/Inclusion: We strive to maintain an atmosphere that reflects our values of inclusion by providing effective and respectful care compatible with each patient and family's beliefs, values, and heritage.


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.


- 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.

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.


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