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Senior Associate III, QA

2 months ago


Irvine, United States BioDuro-Sundia Full time

Pay Range: $69,971-110k

What We Do

BioDuro-Sundia is one of the premier Contract Research, Development and Manufacturing Organizations (CRDMO) globally, with more than 2,200 employees.  Our US operations are US headquartered in Irvine, CA. Our 7 global facilities provide integrated solutions and exceptional services to our clientele for challenging preclinical and clinical trial projects. With capabilities spanning Drug Discovery, Development, and Manufacturing, it is no surprise that BioDuro-Sundia is a leading partner of choice.

Why BioDuro-Sundia?

Take the next step in your career and join BioDuro-Sundia today to change lives through the products we help create. Here, you will contribute your talents to meaningful projects that impact the lives of patients around the world and develop as an individual by working directly with a team of seasoned experts and rising stars. Our values of Accountability, Respect, Tenacity, Results and Integrity are embedded in everything we do. No matter what your role may be, BioDuro-Sundia strives to ensure all our employees are empowered and given the necessary tools to lead us in our relentless pursuit of success.

Requirements

Senior Associate III, QA (Irvine, CA): provide support for pharmaceutical product testing, including in-process, release, stability, method validation; review master/execute batch records; perform investigation/review of product nonconformance; undertake quality product audits; review product stability data; review/approve raw material/packaging component specifications; ensure GMP compliance. Masters (or foreign equiv. deg.) in Chemistry, Pharmaceutics, or rel. + knowledge of analytical QC testing, preparation of SOPs, review of stability data and experimental/engineering batches, oral solid dose manufacturing. Send resume: BioDuro LLC, 9601 Jeronimo Rd., Irvine, CA 92618.