Senior Quality Assurance Specialist

3 weeks ago


Newark, California, United States IDR, Inc. Full time

IDR, Inc. is seeking a seasoned Quality Assurance Specialist II to join our team in the Biotechnology Field. This role offers a unique opportunity for professional growth and development within a large organization.

Position Overview:

The Quality Assurance Specialist II will 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.

Key Responsibilities:

  • 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.

Requirements:

  • 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 We Offer:

Competitive compensation package

Full benefits, including medical, vision, dental, and more

Opportunity to work with an industry-leading organization

Close-knit and team-oriented culture



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