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
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