Senior Quality Assurance Associate

3 weeks ago


New Albany, Ohio, United States Amgen Full time
About the Role

We are seeking a highly skilled and experienced Quality Assurance professional to join our team at Amgen. As a Senior Associate Plant QA, you will play a critical role in ensuring the quality and compliance of our products.

Key Responsibilities
  • Provide QA guidance and support to production teams to ensure compliance with GMP regulations and company policies.
  • Perform quality batch record reviews and other GMP documentation to ensure accuracy and completeness.
  • Collaborate with production operators, production line leads, and other stakeholders to resolve quality-related issues and implement corrective actions.
  • Develop and maintain quality-related procedures and documentation to ensure compliance with regulatory requirements.
  • Participate in internal and external audits to ensure compliance with regulatory requirements and company policies.
Requirements
  • High school diploma or equivalent required; associate's or bachelor's degree in a related field preferred.
  • Minimum 2 years of experience in quality assurance or a related field.
  • Strong knowledge of GMP regulations and company policies.
  • Excellent communication and interpersonal skills.
  • Ability to work independently and as part of a team.
About Amgen

Amgen is a leading biotechnology company that is dedicated to serving patients through the development and delivery of innovative therapies. We are committed to creating a workplace that is inclusive, diverse, and supportive of our employees' growth and development.



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