Quality Assurance Specialist II/III

Seattle Children's•Seattle, WA

8d•$82,736 - $150,166

About The Position

The Quality Assurance Specialist supports or leads clinical research teams at the Ben Towne Center for Childhood Cancer and Blood Disorders Research in developing, implementing, and maintaining quality assurance systems and activities. The position level determines the scope of responsibility. At Specialist II level, the role performs internal audits, assists with site audits, and coordinates the development and review of Standard Operating Procedures. At Specialist III level, the role leads internal audit performance and scheduling, failure investigations, and corrective and preventative action plans; coordinates sponsor audits and competent authority inspections; provides regulatory and quality advice; coordinates Standard Operating Procedures and supporting documents; leads staff training on quality and regulatory topics; represents the department in QA activities; and serves as a primary contact for the department/site program and team.

Requirements

For Specialist II: BA/BS degree in biological sciences or a health-related field, or an equivalent combination of education and experience.
For Specialist II: At least one year of pharmaceutical industry, clinical or biological research, or CRO experience.
For Specialist III: BA/BS degree in biological sciences or another health-related field, or an equivalent combination of education and experience.
For Specialist III: At least five years of healthcare experience in a relevant area, 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 or lead clinical research teams in developing, implementing, and maintaining quality assurance systems and activities.
Perform internal audits and assist with site audits (Specialist II); lead performance and scheduling of internal audits (Specialist III).
Coordinate sponsor audits and competent authority inspections (Specialist III).
Lead failure investigations and corrective and preventative action plans (Specialist III).
Provide regulatory and quality advice and input (Specialist III).
Coordinate the development and review of Standard Operating Procedures; at Specialist III level, also coordinate supporting documents.
Lead quality and regulatory topics 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).