Audit Specialist

Are you passionate about quality and compliance in the pharmaceutical industry? INCOG’s Quality Assurance team is looking for an Audit Specialist to play a key role in ensuring our audit program runs smoothly and effectively.

Requirements

• Coordinate and facilitate client, regulatory, and corporate audit activities, including scheduling, logistics, and preparation of audit rooms and materials
• Serve as a primary point of contact for external auditors during on-site visits, ensuring a professional and organized audit experience
• Collaborate with internal stakeholders across Quality, Manufacturing, Technical Services, Engineering, and Supply Chain to gather and compile supporting documentation in response to audit requests
• Review audit observations, findings, and regulatory citations; assist in drafting clear, accurate, and timely audit responses
• Track and manage audit commitments, ensuring corrective and preventive actions (CAPAs) are appropriately assigned, documented, and completed on schedule
• Maintain the audit schedule and audit tracking systems, ensuring all audit-related records are current and inspection-ready
• Assist in the preparation of front room and back room teams for regulatory inspections, including coordination of subject matter experts (SMEs) and document readiness
• Support internal audit program activities, including scheduling, documentation, and follow-up on observations
• Compile and organize audit metrics, trend data, and summary reports for management review
• Ensure audit-related documentation is maintained in accordance with INCOG’s Quality Management System (QMS) and applicable regulatory requirements
• Participate in continuous improvement initiatives related to the audit program and inspection readiness
• Support the development and revision of SOPs, work instructions, and templates associated with audit and inspection management processes

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Visa Sponsorship
• Four Day Work Week
• Generous Parental Leave
• Tuition Reimbursement
• Relocation Assistance