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 Overview/Responsibilities 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 and/or 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 culture

Why 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