Senior Quality Assurance Auditor

6 days ago


Ada, Ohio, United States AmplifyBio Full time
About AmplifyBio

AmplifyBio is a leading contract research organization that offers a comprehensive range of services, including discovery stage R&D work, preclinical CRO services, and manufacturing services for cell, gene, and mRNA-based therapeutics.

Job Summary

We are seeking a highly skilled Senior Quality Assurance Auditor to join our team. The successful candidate will be responsible for conducting audits and inspections to ensure compliance with federal regulations, AmplifyBio standards, and client specifications.

Key Responsibilities
  • Conduct audits and inspections of AmplifyBio facilities and documentation to ensure compliance with regulatory requirements.
  • Identify and report non-compliance issues to project leadership and management.
  • Develop and execute Quality Assurance Audit Plans per project.
  • Collaborate with operations teams to implement corrective actions and mitigate risk.
  • Stay up-to-date with regulatory requirements and industry standards to ensure compliance.
Requirements
  • Bachelor's degree in a related field or equivalent experience.
  • 2-10 years of experience in a quality assurance program and proven communication skills.
  • Experience in a GLP environment or other regulated QA operations.
What We Offer
  • Competitive compensation package.
  • Flexible PTO policy.
  • Generous paid parental leave.
  • Wellness and self-care programs.
  • 401(k) match.
  • Tuition reimbursement.
  • EAP/work-life support system.

We are an equal opportunity employer and value diversity at our company. We do not discriminate based on race, color, citizenship status, national origin, ancestry, gender, sexual orientation, age, weight, religion, creed, physical or mental disability, marital status, veteran status, political affiliation, or any other factor protected by federal, state, or local law.



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