Quality Assurance Scientist - Biopharma Product Development

Zoetis Inc; Lincoln (NE); Vor Ort; USD 120.000 - 150.000; Vollzeit

Zusammenfassung

Zoetis Inc. in Lincoln, NE, seeks a Scientist for Product Development Quality to provide QA and regulatory expertise for Veterinary Medicine Research & Development (VMRD).

You will oversee compliance during development, transfer of processes, and production to meet US/EU standards and Zoetis requirements. The role requires deep knowledge of cGMP, QA auditing, and regulatory affairs, with the ability to collaborate across DST, VMRA, and GMS teams.

Qualifikationen

• Bachelor's degree with 10 years of relevant experience, or a master's degree with 8 years of relevant experience, or equivalent combination of education and experience in biological or pharmaceutical sciences, engineering, or a related discipline.
• Minimum of 5 years of progressive experience in Quality Assurance, Manufacturing, Quality Control, or Regulatory Affairs within the veterinary or human pharmaceutical or biological products industry.
• Thorough knowledge of U.S. and EU regulations governing biological products and their practical application.

Aufgaben

• Ensure VMRD production facilities and the transfer of newly developed and/or improved biological/biopharmaceutical products and processes comply with applicable USDA, EU, FDA, and Zoetis quality standards, as well as the regulatory requirements of destination countries.
• Review and approve validation protocols and reports.
• Provide guidance and oversight in root cause analysis, CAPAs, and effectiveness checks of CAPAs.
• Advise Management of regulatory deficiencies and recommend appropriate regulatory actions when products do not meet Zoetis or government requirements.
• Maintain up-to-date knowledge in vaccine/biopharmaceutical development and act as a technical resource within the group.

Kenntnisse

QA auditing

cGMP

Regulatory knowledge

Analytical skills

Communication

Lean principles

Ausbildung

Bachelor's degree with 10 years of relevant experience

Master's degree with 8 years of relevant experience

Jobbeschreibung

Zoetis Inc. in Lincoln, NE, seeks a Scientist for Product Development Quality to provide QA and regulatory expertise for Veterinary Medicine Research & Development (VMRD).

You will oversee compliance during development, transfer of processes, and production to meet US/EU standards and Zoetis requirements. The role requires deep knowledge of cGMP, QA auditing, and regulatory affairs, with the ability to collaborate across DST, VMRA, and GMS teams.