Quality Assurance Specialist IV

2 days ago


Newark, United States IDR, Inc. Full time

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 moreOpport
  • 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


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