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Operational Quality Assurance Lead

2 months ago

Fargo, North Dakota, United States Danaher Corporation Full time
About the Role

We are seeking a highly experienced and skilled Operational Quality Assurance Lead to join our team at Danaher Corporation. As a senior-level position, this role will be responsible for leading the Operational Quality Assurance (OQA) team and ensuring the highest standards of quality and compliance in our manufacturing processes.

Key Responsibilities
  • Quality Oversight: Provide timely reviews of all batch documentation to ensure compliance with current Good Manufacturing Practices (cGMP) and current Good Documentation Practices (cGDP) expectations.
  • Process Improvement: Perform evaluations of proposed changes to the manufacturing process, materials, components, or records to determine the effect on the manufactured product and provide recommendations for improvement.
  • Collaboration: Interface with technical operations to develop an understanding of critical process parameters associated with manufacturing deviations that can impact product Quality, Safety, Purity, or Effectiveness.
  • Regulatory Compliance: Interface with regulatory agencies and customers to provide timely documentation and ensure compliance with all relevant regulations.
Requirements
  • 5+ years of experience in a Quality, auditing, or GMP Manufacturing role.
  • Experience working in a regulated or GMP compliant environment.
  • Current or past Quality or auditing certifications a plus (e.g., ISO 9001, ASQ registered inspector, certified internal auditor, etc.).
  • High School Diploma or equivalent GED required.
About Danaher Corporation

Danaher Corporation is a global leader in the life sciences, diagnostics, biotechnology, and beyond. We partner with customers across the globe to help them solve their most complex challenges and accelerate the real-life impact of tomorrow's science and technology.