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The position of Quality Inspection/Audit Support specialist will support Lincoln Operations (Lincoln, NE and Whitehall, IL manufacturing sites) Quality Inspection and Audit program. The Inspection/Audit Specialist will monitor and support new and changing Board of Health regulations to ensure Lincoln Operations maintains alignment with Zoetis markets globally. Support will include working with Lincoln Operations manufacturing sites to identify regulatory gaps, working with site and Zoetis leadership on strategic gap closure plans and manage the implementation of closure plans. This role will also perform internal audits to identify regulatory gaps, check regulatory compliance and ensure effectiveness of corrective and preventative actions (CAPA). For regulatory inspections the Quality Auditor will help provide strategy and subject matter expertise in preparation of, during and post inspection.
- • Monitor and support alignment of new and changing Board of Health Regulations (>10 globally). This will include strategic planning for alignment, reporting status and changes to site and Zoetis leadership, and managing implementation with site SMEs.
- Manage gap closure associated with regulatory inspection findings and changes in current, new and emerging markets. Work with SMEs to perform gap assessments and identify CAPA for gap closure. Liaise with Zoetis management and market regulatory to ensure appropriate communication and action for CAPA closure.
- Perform effectiveness checks on CAPA associated with closure of regulatory findings and changes
- Utilize expertise of quality systems, data integrity, software compliance and GMP requirements to conduct internal quality audits
- Plan and conduct quality assurance audits of Zoetis suppliers and contract service providers: Contract Laboratories, Active Pharmaceutical suppliers, sterilizers, animal-derived raw material suppliers for vaccines, sterile material suppliers, chemical suppliers, critical suppliers, primary and secondary packaging suppliers, warehousing, and distribution sites
- Write audit reports with findings and action items and identifying their significance
- Keep current with company policies, industry guidelines/standards, and government regulations
- Promote continual improvement in the auditing and inspection systems
- Stay current on regulations : USDA, FDA, EU, Russia, Turkey, PICs as well as other emerging market regulations.
- Occasional travel required
Education and Experience
- Undergraduate degree in engineering, science, or other degree with applicable experience
- Ten years related experience. The related experience should be in one or more of the following disciplines: Quality Assurance or Sterile and Non-Sterile Manufacturing
- > 5 years’ project management of multi-disciplinary teams
- 2-4 years of relevant experience applying regulations and communicating with regulatory agencies, Animal Health/ Pharma industry.
- Familiarity with USDA, FDA, EU, and foreign regulatory laws
- > 4 years of relevant experience applying regulations and communicating with regulatory agencies, Animal Health/ Pharma industry. Including experience conducting site audits and assessments, both internal and external (e.g. suppliers, contract service)
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
- High level of understanding of the criteria for selection for supplier management and GMP auditing services in the Biological and Pharmaceutical Industry
- 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
- Extensive experience with Excel and PowerPoint
- Proficiency in English