Connor Hiltwine

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!

• 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

• 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