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:Bachel
- or's degree in biology, biochemistry or related pharmaceutical-biotechnology disciplineMinimu
- m of 3 years work experience within a GMP environmentExperi
- ence with a wide range of analytical techniques such as ELISA, SDS-PAGE, Western Blot, Karl Fischer, UV and HPLCSolid
- technical training and troubleshooting experienceStrong
- understanding of data integrity principles within a GMP environmentExpert
- ise in use of Microsoft Office applicationsWhat's
in it for you?Compet
- itive compensation packageFull B
- enefits; Medical, Vision, Dental, and more!Opport
- unity to get in with an industry leading organizationClose-
- knit and team-oriented cultureWhy ID
R?25+ Ye
ars of Proven Industry Experience in 4 major marketsEmployee Stock Ownership ProgramMedical, Dental, Vision, and Life InsuranceClearlyRated's Best of Staffing® Client and Talent Award winner 11 years in a row