Quality Assurance Specialist

5 days ago


Pasco, Washington, United States AGC Biologics Full time
Job Summary

We are seeking a highly skilled Quality Assurance Specialist to join our team at AGC Biologics. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our biologics manufacturing operations.

Key Responsibilities
  • Support the manufacture of biologics by providing QA support to operations and ensuring compliance with cGMP, FDA, and ICH regulations.
  • Review and approve Master Production Records (MPRs) and other support documentation for completeness, compliance, and accuracy.
  • Collaborate with stakeholders to resolve GMP errors and deviations.
  • Review and approve QC data generated from manufactured product and intermediates.
  • Support the issuance of Master Production Records and other records as needed.
  • Review and approve preventative maintenance and repair work orders related to equipment or facilities.
  • Review raw material testing for release to manufacturing operations.
  • Initiate and participate in process improvement activities to enhance compliance and efficiency.
  • Collaborate with manufacturing operations to resolve issues, non-conformities, and deviations.
  • Provide general support for other shifts as needed.
Requirements
  • Bachelor's degree in Biology, Chemistry, or a related field.
  • Direct Quality Assurance experience preferred.
  • 5+ years of QA-related experience, including interpretation and application of regulatory principles.
What We Offer

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement.

Our Culture

Our culture at AGC Biologics is defined by six core values: Knowledge, Trust, Quality, Ingenuity, Accountability, and Teamwork. These values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.



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