Biologics Manufacturing Quality Associate

1 week ago


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

We are seeking a highly skilled Quality Assurance Specialist to support our Biologics Manufacturing operations. The successful candidate will be responsible for reviewing inputs necessary to execute batch disposition, collaborating with cross-functional teams, and ensuring compliance with cGMP regulations and client expectations.

Key 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 to support product lot disposition.
  • Collaborate with stakeholders to resolve GMP errors and initiate process improvement activities for quality processes.
  • Review and approve preventative maintenance and repair work orders related to equipment or facilities.
  • Review raw material testing for release to manufacturing operations and provide guidance to other QAs in the solution of issues associated with production batches.
  • Act as the primary QA point-of-contact to escalate problem resolution to management and provide guidance for manufacturing activities to resume.
  • Provide general support for other shifts, as needed, for activities from Manufacturing, Quality Control, and Engineering Operations.
Requirements
  • BS degree in Biology, Chemistry, or other relevant discipline or equivalent work experience.
  • Direct Quality Assurance experience preferred.
  • 5+ years of QA-related experience, including interpretation and application of regulatory principles which drive QA strategy.
Our Company

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells.

We currently employ more than 2,500 employees worldwide and have a global network spanning the U.S., Europe, and Asia. Our commitment to continuous innovation fosters the technical creativity to solve our clients' most complex challenges, including specialization in fast-track projects and rare diseases.

AGC Biologics is the partner of choice for our clients, and we are committed to providing a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement.



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