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Last Updated: 4/30/21

Job Description

POSITION SUMMARY

The Quality Auditor will manage the internal audit program by developing a plan using a risk basd approach and conducting audits of the Union City manufacturing site with the goal of determining compliance gaps and necessary remediation plans. The Quality Auditor will promptly deliver/communicate audit findings using predetermined processes and methodology.

The Quality Auditor will need to collaborate with functional areas to to identify the potential auditor resource, prepare annual audit plan and act as trainer / tutor to train & support the supporting auditors.

The Quality Auditor will support mock regulatory inspections as needed as well as support agency inspections. Additonally – the Quality Auditor will gather, track, trend, and disseminate regulatory compliance findings – from internal as well as external inspection sources. The incumbent will work closely with QSS and Surveillance colleagues to stay abreast of current compliance regulations and points of key inspection trends.

POSITION RESPONSIBILITIES

  • Perform the full audit cycle including risk management and control management over operation
  • Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits
  • Organize, conduct quality audits for the Zoetis Union City location and support audits for for Suppliers and Service providers.
  • Notify Management of potential Critical Findings
  • Notify Coordinators and site leadership team for audit refusals
  • Update Global Audit solution with audit dates, preparation of audit reports and Observations, request for approval and close the audits
  • Maintain master data in ETS and update the aduit status timely. Trainer supporting auditors.
  • Distribute audit report as designated
  • Conduct Mock PAI and inspection readiness assessments at the site.
  • Support regulatory agency inspections, conduct risk assessment of regulatory agency observations and report to upper management if necessary
  • Follow up of CAPA plans with Auditees and track CAPA for completion in the case of GMS sites or for Critical findings
  • Provide support to GMS sites (buddy sites) as deemed necessary in the preparation of Risk Assessments and review data provided
  • Train sites and colleagues on conducting audits (auditor qualification)
  • Provide technical expertise as requested and conduct business interactions in ways that reinforce and compliment Zoetis quality assurance programs.
  • Zoetis Quality Culture ambassidor

ORGANIZATIONAL RELATIONSHIPS

  • Manufacturing Operations
  • QSS, QPL
  • VMRA VMRD
  • GSS
  • Manufacturing IT

RESOURCES MANAGED

Supervision

  • Highly matrixed organization; Influence without authority necessary

EDUCATION AND EXPERIENCE

  • Science or Engineering Bachelors / Masters Degree
  • At minimum 5 years GMP/GDP audit experience
  • Demonstrated ability to operate successfully in a matrix organization
  • Experience in working with FDA, EU, USDA, others authories
  • ASQ, CQA, CQE preferred.

TECHNICAL SKILLS REQUIREMENTS

  • Demonstrated knowledge in Quality Operations and / or manufacturing
  • Fluent with compliance regulators
  • Excellent communication skills (written, oral, and listening)
  • Demonstrated independent contributor and ability to manage independently
  • Deep expertise in planning, organizing, and follow up audit methodology; punctual
  • Ability to develop and adhere to self-directed standard work.
  • Ability to analyze data and synthesize to enable tracking and trending of large issues
  • Process Owner Management
  • Continuous Improvement; Systems and Process mindset
  • Fluent English speaker and strong interpersonal skill

PHYSICAL POSITION REQUIREMENTS

  • Location: Union City, CA
  • Position requires flexible work hours, to accommodate varying sites, locations, and markets’ time zones
  • This position will require fluent use of teleconferencing,Webex and Teams tools, as well as Sharepoint technologies, to share and manage information with global locations and manufacturing sites
  • Travel: 10% travel

ACRONYM DEFINITIONS

  • QSS: Quality Systems and Standards
  • QPL: Quality Platform Leader
  • QA: Quality Assurance
  • QC: Quality Control
  • ESQA: External Supply Quality Assurance
  • SC QO: Supply Chain Quality Operations
  • GMS: Global Manufacturing and Supply
  • VMRA: Vetrinary Medicine Regulatory Affairs

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.