Biopharmaceutical Quality Assurance Specialist

2 days ago


Pasco, Washington, United States AGC Biologics Full time
About the Role:

We are seeking a skilled Quality Assurance Associate III to join our team in [Location]. As a key member of our operations, you will play a critical role in ensuring the quality and compliance of our biologics manufacturing processes. This is a challenging and rewarding position that requires strong analytical skills, attention to detail, and excellent communication abilities.

Responsibilities:
  • Support the manufacture of biologics by providing QA support to operations and ensuring compliance with cGMP, FDA, and ICH regulations.
  • Review executed Master Production Records (MPRs) and other support documentation for completeness, compliance, and accuracy.
  • Collaborate with stakeholders to resolve GMP errors and initiate process improvement activities to enhance compliance and efficiency.
  • Collaborate with manufacturing operations in the resolution of issues, non-conformities, and deviations.
  • Provide general support for other shifts, as needed, for activities from Manufacturing, Quality Control, and Engineering Operations.
Requirements:
  • Bachelor's degree in Biology, Chemistry or other relevant discipline or equivalent work experience.
  • 5+ years of QA-related experience, including interpretation and application of regulatory principles which drive QA strategy.
  • Strong understanding of basic scientific/technical concepts and ability to interact and lead when appropriate with cross-functional teams.
What We Offer:
  • A highly competitive compensation package with an estimated salary range of $74,960 - $103,070.
  • A friendly, collaborative culture that values personal initiative and professional achievement.
  • The opportunity to work with a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO).


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