Operational Quality Assurance Lead

2 days ago

Fargo, North Dakota, United States Danaher Corporation Full time
Job Title: Operational Quality Assurance Lead

At Danaher Corporation, we are committed to accelerating the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

We are seeking an experienced Operational Quality Assurance Lead to join our team in Fargo, ND. As a key member of our Quality Assurance team, you will be responsible for driving coordination of real-time review activities, training, mentoring, and coaching lower-level OQA associates.

Key Responsibilities:
  • Cross-functional support including gap analysis, FMEA, risk assessments, root cause analysis, tracking and trending, statistical modeling, and develop/maintain client-specific process datasets.
  • Follow, revise, and edit SOPs and forms to confirm compliance to a standard.
  • Coordination and responsibility for collaboration with Manufacturing in respect to any Quality-related activities identified during manufacturing.
  • Perform GMP oversight and real-time review of manufacturing documentation, including batch records and protocols during execution.
  • Monitor and audit processes to ensure protocols are being met.
  • Timely reviews of all batch documentation, ensuring batch records are complete, correct, accurate, and satisfy all current Good Manufacturing Practices (cGMP) and all current Good Documentation Practices (cGDP) expectations.
  • Interfaces with technical operations to develop an understanding of the critical process parameters associated with manufacturing deviations that can impact product Quality, Safety, Purity, or Effectiveness.
  • Provide technical Quality oversight to manufacturing Quality Events investigations.
  • Interface with regulatory agencies and customers to provide timely documentation.
  • Evaluations of proposed changes to the manufacturing process, materials, components, or records to determine the effect on the manufactured product.
  • Recommendations to correct, enhance, improve, or optimize any underperforming process and creating and amending work instructions, as needed.
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 GED equivalent.

We value diversity and the existence of similarities and differences found in our workforce, workplace, and throughout the markets we serve. Our associates, customers, and shareholders contribute unique and different perspectives as a result of these diverse attributes.

We are an equal opportunity employer and are committed to providing reasonable accommodation to individuals with disabilities. Please contact us at [email protected] to request accommodation.

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