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(Archived) Quality Inspection Audit Specialist

Last Updated: 6/23/21

Job Description

Position Summary

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.

Position Responsibilities

  • • 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

Required

  • 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

Preferred

  • > 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

Full time

Regular

Colleague

Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at [Register to View] to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at www.Zoetis.com/careers site, or (2) via email to/from addresses using only the Zoetis domain of [Register to View] In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.

Company Details

Parsippany, New Jersey, United States
Zoetis discovers, develops, manufactures and commercializes medicines, vaccines and diagnostic products, which are complemented by biodevices, genetic tests and precision livestock farming. Zoetis serves veterinarians, livestock producers and people who raise and care for farm and companion animals in more than 100 countries.