Quality Assurance Specialist II/III

Seattle Children's Hospital•Seattle, WA

About The Position

Seattle Children’s is hiring at the Quality Assurance Specialist II or III level to support clinical research teams at the Ben Towne Center for Childhood Cancer and Blood Disorders Research. The Specialist II assists with developing, implementing, and maintaining quality assurance systems and activities, performs internal audits, assists with site audits, and coordinates the development and review of Standard Operating Procedures (SOPs). The Specialist III leads the development, implementation, and maintenance of quality assurance systems and activities. This level leads internal audit performance and scheduling, failure investigations, corrective and preventive action plans, and coordination of sponsor audits and competent-authority inspections. The Specialist III also provides regulatory and quality advice, coordinates SOP and supporting-document development and review, leads quality and regulatory training for staff, represents the department in QA activities, and serves as a primary contact for the department/site program and team. The role requires a relevant bachelor’s degree or equivalent education and experience. Required experience varies by level. A master’s degree in a healthcare-related field and experience in quality, regulatory, accreditation, or healthcare programs are preferred. The listed compensation range is $82,736–$150,166 per year and is specific to Seattle; positions outside Seattle may have different compensation. Seattle Children’s offers medical, dental, and vision plans, a 403(b), life insurance, paid time off, tuition reimbursement, and other benefits.

Requirements

Specialist II: BA/BS degree in biological sciences or a health-related field, or an equivalent combination of education and experience.
Specialist II: Minimum of one year of pharmaceutical industry, clinical or biological research, or CRO experience.
Specialist III: BA/BS degree in biological sciences or another health-related field, or an equivalent combination of education and experience.
Specialist III: Minimum of five years of healthcare experience in areas such as clinical laboratory, blood bank, cellular therapy collection or processing, oncology specialties including nursing, healthcare accreditation and compliance, or other healthcare-related experience; alternatively, three years of direct experience with all regulations related to the department’s primary work.

Nice To Haves

Master’s degree in a healthcare-related field.
Experience in quality assurance or quality control.
Experience with regulatory or accreditation requirements.
Experience administering regulatory accreditation and compliance programs.
Healthcare experience related to the Department/Site’s focus.

Responsibilities

Assist clinical research teams with developing, implementing, and maintaining quality assurance systems and activities (Specialist II).
Perform internal audits and assist with site audits (Specialist II).
Coordinate development and review of Standard Operating Procedures (Specialist II).
Lead clinical research teams in developing, implementing, and maintaining quality assurance systems and activities (Specialist III).
Lead the performance and scheduling of internal audits, failure investigations, and corrective and preventive action plans (Specialist III).
Coordinate sponsor audits and competent-authority inspections (Specialist III).
Provide regulatory and quality advice and input (Specialist III).
Coordinate development and review of Standard Operating Procedures and supporting documents (Specialist III).
Lead quality and regulatory topic training for staff (Specialist III).
Represent the department in QA activities and serve as a primary contact for the department/site program and team (Specialist III).