QA Specialist: GMP Compliance & Regulatory Readiness

Zoetis Inc; Virginia; Vor Ort; USD 70.000 - 90.000; Vollzeit

Zusammenfassung

Zoetis Inc. seeks a Quality Assurance professional to collaborate with manufacturing colleagues as a cross-functional team member and approver of investigations, ensuring compliance with local policies.

Responsibilities include approvals of GMP deviations, audits of construction activities, and SAP dispositions. You will review batch records and related documents to support timely product release and participate in regulatory inspections, quality system SOPs, and CAPA processes.

Qualifikationen

• CAPA, Analytical Problem Solving and Root Cause Analysis training preferred. Basic problem-solving skills.
• Excellent verbal and written communication skills, fluent in English.
• Proficient with the following software programs: SAP, Word, Excel, and PowerPoint.

Aufgaben

• Actively support, review and approve of all manufacturing/environmental/ GMP deviations as well as related items (Visual mapping boards, action items, commitments tracking, etc.) related to manufacture of veterinary biological products at the Charles City, Iowa facility.
• Conduct walks through audits as part of the paint and patch process as well as ongoing construction activities being conducted at the site. Audits may consist of pre and post reviews as well as various system verifications.
• Performs product related SAP system dispositions based on local site procedures.
• Participates in the Change Management process as a Quality SME.
• Participate in the preparation for and execution of regulatory agency inspections.
• Develop/revise, implement and maintain assigned Quality Assurance standard operating procedures to ensure compliance with regulatory and quality standards requirements.
• Perform batch record reviews and reviews of other records relating to the processing of components, materials and finished veterinary biologicals for comparison with approved specifications and regulatory requirements as necessary to support timely release of product.
• Audit manufacturing processes for compliance against internal and regulatory filings (ZQS, PP, EU dossier, other markets).

Kenntnisse

CAPA

Analytical Problem Solving

Root Cause Analysis

Verbal Communication

Written Communication

SAP

Word

Excel

PowerPoint

Ausbildung

BA/BS with 0-2 years experience

BA/BS with 2-4 years experience

Tools

SAP

Word

Excel

PowerPoint

Jobbeschreibung

Zoetis Inc. seeks a Quality Assurance professional to collaborate with manufacturing colleagues as a cross-functional team member and approver of investigations, ensuring compliance with local policies.

Responsibilities include approvals of GMP deviations, audits of construction activities, and SAP dispositions. You will review batch records and related documents to support timely product release and participate in regulatory inspections, quality system SOPs, and CAPA processes.