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Quality Assurance Engineer
Quality Assurance Specialist
• Demonstrates proficiency in Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
• Demonstrates through knowledge of Information Systems Technology, understanding of Computer System Validation (CSV) including current electronic records and signature requirements.
• Demonstrates proficiency in application of QA principles, concepts, industry practices, and standards.
• Demonstrates thorough knowledge of FDA / EMEA standards and quality systems, and the interface with other functions like manufacturing, distribution and maintenance.
• Demonstrates ability to facilitate, collaborate and lead the discussions for Change Proposal, Deviation Investigation, CAPA and author quality records
• Demonstrates strong knowledge of six sigma, LEAN and root cause analysis tools used for identifying and correcting deviations
• Demonstrates audit and investigation skills, and report writing skills.
• Demonstrates strong verbal, technical Business language writing skills and interpersonal skills.
• Demonstrates proficiency in Microsoft Office applications.
• 6+ years of relevant experience in a GxP environment related field and a BS/BA degree
• 4+ years of relevant experience and a MS.
• Prior experience in pharmaceutical industry is preferred.