Quality Assurance Specialist IV
IDR

Newark, California

Posted in Manufacturing and Production


Job Info


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

  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. IDR is subject to certain governmental recordkeeping and reporting requirements for the administration of civil rights laws and regulations. In order to comply with these laws, we invite employees to voluntarily self-identify their race or ethnicity, gender, and veteran status (if applicable). Submission of this information is voluntary and refusal to provide it will not subject you to any adverse treatment. The information obtained will be kept confidential and may only be used in accordance with the provisions of applicable laws, executive orders, and regulations, including those that require the information to be summarized and reported to the federal government for civil rights enforcement. You may access this form 



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