Quality Audit Specialist

Essential Duties and Responsibilities

• Manage the Supplier and Internal Audit Program including preparation, scheduling and monitoring of audit activities
• Ensure audit deliverables, responses, corrective action commitments, and associated documentation are completed accurately and within required timelines
• Cookordinate and host customer QA and qualification audits
• Plan, conduct, and document internal and supplier audits to assess compliance with applicable regulations, customer requirements, and company procedures
• Review, communicate, and track audit observations, deviations, and compliance gaps to ensure timely implementation and closure of corrective actions
• Support regulatory and agency inspections, audits, investigations and inquiries
• Responsible for maintenance of the approved/qualified supplier listings and service provider listings
• Prepare audit reports, document audit observations, and create and track CAPAs related to audit findings
• Identify audit trends, systemic issues, and opportunities for improvement, and partner with cross-functional teams to drive sustainable compliance and quality system enhancements
• Identify recurring compliance risks and systemic issues through audit activities and support implementation of effective corrective and preventive measures to improve quality system performance
• Performs special projects and/or assignments as indicated by Quality Management
• Support requests from internal and external customers as needed

Qualifications

• Bachelor’s Degree, Associates Degree, or equivalent in science or technical related field preferred
• Minimum 3 years relevant work experience in a cGMP environment
• Advanced knowledge of GMPs, Auditing and Quality Assurance/Quality Control skills and the ability to communicate this knowledge to the organization professionally and succinctly
• Quality Assurance experience in an operational or development setting with demonstrated knowledge of techniques for assessing the quality of processes and the ability to guide others in these activities
• Must be able to travel up to 25% (domestic)