Senior Quality Assurance Compliance Specialist

2 days ago


Albany, New York, United States AmplifyBio Full time
AmplifyBio is Seeking a Senior Quality Assurance Compliance Specialist

AmplifyBio, a leading contract research organization, is seeking a highly skilled Senior Quality Assurance Compliance Specialist to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the quality and compliance of our products and services.

Key Responsibilities:

  • Develop and implement quality management systems to ensure compliance with regulatory requirements.
  • Conduct supplier qualification and auditing to ensure the quality and reliability of our suppliers.
  • Manage and execute audit programs to ensure compliance with regulatory requirements.
  • Develop and maintain quality procedures and documentation to ensure compliance with regulatory requirements.
  • Collaborate with cross-functional teams to ensure quality and compliance in all aspects of our business.

Requirements:

  • Bachelor's degree in a relevant scientific discipline, such as biochemistry, biology, or chemistry.
  • Minimum 5 years of experience in quality assurance and regulatory compliance in a GxP environment.
  • Strong knowledge of regulatory requirements, such as 21 CFR Part 210 and 211.
  • Excellent communication and interpersonal skills.
  • Ability to work in a fast-paced environment and prioritize multiple tasks.

What We Offer:

  • Competitive salary and benefits package.
  • Opportunity to work with a leading contract research organization.
  • Collaborative and dynamic work environment.
  • Professional development opportunities.

AmplifyBio is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive and respectful work environment that values diversity and promotes equal opportunities for all employees.



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