Senior Quality Assurance Specialist

1 week ago


Easton, Pennsylvania, United States Avantor Full time

Are you passionate about ensuring the highest quality standards in a dynamic and fast-paced environment? Do you have a strong background in quality assurance and regulatory compliance? We are seeking a highly motivated and experienced Quality Engineer II to join our team at Avantor.

The successful candidate will lead our site quality assurance programs and initiatives, ensuring compliance with regulatory standards such as cGMPs, ICHQ7, IPEC guidelines, ISO regulations, and FDA requirements. You will be responsible for managing audit activities, driving improvements in quality management systems, and collaborating with various departments to resolve quality issues and support overall site performance.

About the Role:

  • Lead site quality assurance programs and initiatives to ensure compliance with regulatory standards.
  • Manage audit activities, including GMP, regulatory, customer, and internal audits.
  • Drive improvements in quality management systems to meet global metrics.
  • Collaborate with various departments to resolve quality issues and support overall site performance.
  • Develop and implement effective corrective actions to address quality-related issues.
  • Provide GMP and GDP training to site personnel.
  • Work collaboratively with external customers, operations leadership, and interact with all levels of plant operations, R&D, procurement, commercial, and quality teams.

Requirements:

  • Bachelor's Degree in Chemistry or a related field.
  • Minimum of five (5) years of experience in quality engineering or a related role.
  • Experience working within pharmaceutical, biotechnology, and/or chemical environments.
  • Excellent writing and presentation skills.
  • Demonstrated ability to accomplish goals through others.
  • Demonstrated familiarity with chemical nomenclature and Quality Control testing and methods.

Estimated Salary: $95,000 - $115,000 per year.

Why Choose Avantor?

  • We offer a dynamic and challenging work environment that allows you to grow your career.
  • We provide opportunities for professional development and training to enhance your skills.
  • We foster a culture of innovation, teamwork, and collaboration.
  • We prioritize employee well-being and offer a comprehensive benefits package.


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