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Quality Assurance Senior Associate III

2 months ago

Irvine, California, United States BioDuro-Sundia Full time

Compensation Range: $69,971-110k

Company Overview

BioDuro-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 outstanding services for complex preclinical and clinical trial initiatives. Our expertise encompasses Drug Discovery, Development, and Manufacturing, making BioDuro-Sundia 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 support. Here, you will apply your skills to impactful projects that enhance the lives of patients globally while growing 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 essential resources needed to excel in our continuous quest for success.

Position Overview

The Senior Associate III, QA role involves providing essential support for pharmaceutical product evaluation, which includes in-process testing, release testing, stability assessments, and method validation. Key responsibilities include:

  • Reviewing master and executing batch records
  • Conducting investigations and reviews of product nonconformance
  • Performing quality product audits
  • Evaluating product stability data
  • Reviewing and approving specifications for raw materials and packaging components
  • Ensuring compliance with Good Manufacturing Practices (GMP)

Qualifications include a Master's degree (or equivalent) in Chemistry, Pharmaceutics, or a related field, along with a solid understanding of analytical quality control testing, preparation of Standard Operating Procedures (SOPs), and review of stability data and experimental batches in oral solid dose manufacturing.