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Will McDonald

4.83
from 30 reviews
Job
Quality Assurance Specialist IV
Newark , California, United States
CONTRACT
TERMS: contract
START DATE: 12/19/24

IDR is seeking a Quality Assurance Specialist IV to join one of our top clients in Newark, CA. This role is perfect for individuals with a strong background in biology, biochemistry, or a related pharmaceutical-biotechnology discipline, and a minimum of 3 years of experience in a GMP environment. 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 IV:
  • Provide compliance support or oversight for operational functions

  • Conduct investigations for Laboratory Investigation Reports (LIR) and deviations via effective root cause analysis

  • Author and revise controlled documents such as procedures, methods, work instructions, protocols, and reports

  • Perform risk analysis as needed to determine severity, likelihood of recurrence when triaging events and/or conducting investigations

  • Manage and author change controls related to qualification, modification, and/or decommissioning of equipment

Required Skills for Quality Assurance Specialist IV:
  • Bachelor's degree in biology, biochemistry or related pharmaceutical-biotechnology discipline

  • Minimum of 3 years work experience within a GMP environment

  • Experience with a wide range of analytical techniques such as ELISA, SDS-PAGE, Western Blot, Karl Fischer, UV and HPLC

  • Solid technical training and troubleshooting experience

  • Strong understanding of data integrity principles within a GMP environment

  • Expertise in use of Microsoft Office applications

     

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?

  • 25+ 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