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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.
- 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
- Manufacturing Operations
- QSS, QPL
- VMRA VMRD
- Manufacturing IT
- 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
- 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