Quality Assurance Specialist II

IDR is seeking a Quality Assurance Specialist II to join one of our top clients in Newark, CA This role is a unique opportunity for a seasoned professional to take grow and develop within the Biotechnology Field. If you are looking for an opportunity to join a large organization and work within a team-oriented culture, please apply today!Position OverviewResponsibilities for the Quality Assurance Specialist II :Perform a wide variety of quality assurance activities to ensure compliance with procedures and applicable US and international regulatory requirements for biologic substances and drug products under clinical development.Manage the reserve sample program, conduct incoming quality attribute inspections, and review and dispose of incoming raw materials.Coordinate and track the closure of change controls, deviations, quality investigations, and CAPAs, while preparing quality system metrics.Support quality operations as needed, assist in internal compliance audits, and provide inspection readiness support during regulatory inspections.Required Skills for Quality Assurance Specialist II:Minimum of 4 years of experience performing quality functions in pharmaceutical andor biotech fields, with some working knowledge of quality systems and cGMP standards applicable to clinical biologics DS and DP.Works under moderate supervision, demonstrating the ability to independently analyze and reconcile simple issues.Capable of organizing and managing multiple tasks in a fast-paced environment, requiring minimal instruction on routine work and moderate guidance on new assignments.Possesses strong verbal and written communication skills, along with effective interpersonal abilities.What's in it for you?- Competitive compensation package- Full Benefits; Medical, Vision, Dental, and more!- Opportunity to get in with an industry leading organization- Close-knit and team-oriented cultureWhy IDR?- 20+ Years of Proven Industry Experience in 4 major markets- Employee Stock Ownership Program- Medical, Dental, Vision, and Life Insurance- ClearlyRated's Best of Staffing® Client and Talent Award winner 11 years in a row

Created: 2024-10-28