Quality Assurance Manager

19 hours ago


New Albany, Ohio, United States Amplifybio, LLC Full time
About the Role

We are seeking a highly skilled and experienced Quality Assurance Manager to join our team at AmplifyBio, LLC. In this role, you will be responsible for ensuring the quality of our products and services, as well as ensuring compliance with relevant regulations.

Job Summary

The Senior QA Compliance Specialist is responsible for executing the Quality Management System for the New Albany GMP facility. This includes ensuring Quality Events are performed in a timely manner to meet quality and business objectives.

Key Responsibilities:
  • Implement and manage systems for Quality Management, Quality Assurance, Data stewardship, and governance.
  • Maintain complaint and nonconformance processing through records and tracking systems, including FMEA, root-cause analysis and corrective actions.
  • Participate in drafting quality assurance agreements as required.
  • Analyze operational and delivery processes, and ensure that they comply with company standards, industry regulations, state/federal laws, and sets the standard for best practices.
  • Ensure product and facility compliance with AmplifyBio policies and procedures, US and Global Quality System Regulations including, but not limited to 21CFR11, 21CFR210, 21CFR211, and EudraLex Volume 4 Annex 1.
Requirements

To be successful in this role, you will need:

  • A Bachelor's degree or higher in a relevant scientific discipline or equivalent education and experience.
  • A minimum of 5+ years of experience within the Quality Unit in a GMP pharmaceutical environment.
  • Experience with deviation and CAPA management, ASQ Certified Pharmaceutical GMP Professional a strong plus.
  • Ability to work with minimal supervision.
  • Strong interpersonal skills, ability to work in a team environment, attention to details and excellent problem resolutions skills.
Benefits

We offer a competitive salary range of $120,000 - $150,000 per year, depending on experience, as well as a comprehensive benefits package, including:

  • Health, Dental, and Vision insurance that starts on your first day.
  • Competitive Compensation Package.
  • UNLIMITED PTO policy.
  • Generous paid parental leave.
  • Wellness and Self-Care Programs.
  • 401(k) match.
  • Tuition Reimbursement.
  • EAP/work-life support system.


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