Senior Quality Assurance Associate III
1 week ago
Compensation Range: $69,971-110k
Company Overview
BioDuro-Sundia stands as a leading Contract Research, Development, and Manufacturing Organization (CRDMO) worldwide, employing over 2,200 professionals. Our operations are based in the United States, with a headquarters in Irvine, CA. We operate seven global facilities that deliver integrated solutions and exceptional services to our clients, particularly in the realm of preclinical and clinical trial projects. Our extensive capabilities encompass Drug Discovery, Development, and Manufacturing, establishing BioDuro-Sundia as a preferred partner in the industry.
Why Choose BioDuro-Sundia?
Advance your career with BioDuro-Sundia and make a difference through the innovative products we help develop. Here, you will apply your skills to impactful projects that enhance the lives of patients globally, while also growing personally and professionally alongside a team of experienced professionals and emerging talents. Our core values—Accountability, Respect, Tenacity, Results, and Integrity—are integral to our operations. Regardless of your position, BioDuro-Sundia is committed to empowering all employees and providing the necessary resources to drive our continuous pursuit of excellence.
Position Overview
The Senior Associate III, QA role involves supporting pharmaceutical product testing, which includes in-process testing, release testing, stability assessments, and method validation. Responsibilities also include reviewing master and executing batch records, conducting investigations and reviews of product nonconformance, performing quality product audits, analyzing product stability data, approving raw material and packaging component specifications, and ensuring compliance with Good Manufacturing Practices (GMP).
Qualifications
The ideal candidate will possess a Master's degree (or foreign equivalent) in Chemistry, Pharmaceutics, or a related field, along with knowledge of analytical quality control testing, the preparation of Standard Operating Procedures (SOPs), stability data review, and experimental or engineering batch processes, particularly in oral solid dose manufacturing.
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Senior Quality Assurance Associate III
2 weeks ago
Irvine, California, United States BioDuro-Sundia Full timeCompensation Range: $69,971-110kAbout UsBioDuro-Sundia stands as a leading Contract Research, Development, and Manufacturing Organization (CRDMO) on a global scale, employing over 2,200 professionals. Our operations are primarily based in the United States, with our headquarters located in Irvine, CA. We operate 7 facilities worldwide, delivering...
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Quality Assurance Senior Associate III
1 week ago
Irvine, California, United States BioDuro-Sundia Full timeCompensation Range: $69,971-110kCompany OverviewBioDuro-Sundia stands as a leading Contract Research, Development, and Manufacturing Organization (CRDMO) on a global scale, employing over 2,200 professionals. Our operations in the United States are based in Irvine, CA, and we operate seven facilities worldwide, delivering comprehensive solutions and...
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