(Archived) Quality Audit Support Specialist

Position Summary

The Quality Auditor support position is responsible for conducting assigned internal and external audits in alignment with the Zoetis policies and strategies, applicable regulations and internal procedures. This position will also work with suppliers and service providers to investigate complaints, non-conformances and significant changes as well as obtaining quality information/documentation to support qualification activities. The Quality Audit Support Specialist will also be responsible for providing support during and after site regulatory inspections.

Position Responsibilities

• Plan and conduct assigned quality assurance audits of Zoetis suppliers and contract service providers
• Plan and conduct assigned quality assurance audits of Lincoln Operations
• Write audit reports with findings and action items and identify their significance
• Lead discussions and conduct formal investigations, as needed, with suppliers to address non-conformances, complaints and significant changes
• Work with Lincoln Operations Subject Matter Experts and Suppliers to coordinate and collect needed quality information/documentation for qualification
• Support activities to assign risk level and audit type to Lincoln Operations Suppliers
• Support continual improvement in the auditing and inspection systems
• Provide guidance on issues such as deviations and non-conformances resulting from an audit or regulatory inspection
• Keep current with company policies, industry guidelines/standards, and government regulations
• Support other quality systems and projects as needed
• Travel up to 30% of the time

Education and Experience

Required

• Undergraduate degree in engineering, science, or other degree with applicable experience
• 3-5 years related experience. The related experience should be in one or more of the following disciplines: Quality Assurance or Sterile and Non-Sterile Manufacturing
• Familiarity with USDA, FDA, EU, and foreign regulatory laws

Preferred

• 1-3 years of relevant experience in auditing, Animal Health/ Pharma industry
• >5 years related experience. The related experience should be in one or more of the following disciplines: Quality Assurance or Sterile and Non-Sterile Manufacturing

Relevant advanced degree or training/certificate in auditing preferred

Technical Skills and Competencies

• Quality orientation and high attention to detail
• Strong working knowledge of cGMPs (Pharmaceuticals & Vaccines)
• Exceptional communicator with strong persuasion skills and presentations
• Excellent analytical skills and the ability to access and resolve difficult compliance situations
• Demonstrated ability to troubleshoot and reach targeted conclusions
• Excellent interpersonal effectiveness and communication skills (written and oral) required to interface with Zoetis suppliers and across departments, sites and management levels
• Proven ability to operate in an independent manner and manage multiple projects at one time
• Proven ability to lead high visibility and multi-disciplinary investigations and projects
• Proficiency in English

Physical Position Requirements

None