Quality Assurance Specialist II, GMP Clinical Manufacturing

Assist members of the TCPC 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, and coordinate the development and review of Standard Operating Procedures.

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 of biotechnological or pharmaceutical industry hands on QA experience in a GMP manufacturing environment. Preferred: - Knowledge of the regulatory (cGMP, GLP, CBER, etc) and technical (production and testing methodologies of cell-based products.

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.