Quality Assurance Auditor I -WYEYH-US- Charles City-IA-United States

RESPONSIBILITIES
• Perform assigned batch record reviews and review of other records relating to the processing of components, materials and finished veterinary biologicals for comparison with approved specifications and regulatory requirements.
• Review and approve assigned new and revised documents (e.g., specifications, procedures, processes, methods, protocols and reports) associated with veterinary biological production and production support operations.
• Participate in the preparation for and execution of foreign and domestic regulatory agency inspections.
• Develop/revise, implement and maintain assigned Quality Assurance standard operating procedures to ensure compliance with domestic and international regulatory and quality standards and requirements.
• Perform and document assigned floor audits.
• Audit manufacturing processes for compliance against approved regulatory licenses.
• Cross train with production supervisory functions for greater depth of understanding of process flow.

BASIC QUALIFICATIONS:
• A minimum of six (6) years biological and/or pharmaceutical industry experience

.• Thorough understanding of cGMPs, and domestic and international regulations and requirements, with a strong ability to understand and interpret regulations.

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