QA Specialist

Contract duration: 30 June 2025

Responsibilities:

• Provide immediate support to operations and quality control staff to address compliance related concerns.
• Make independent quality-related decisions based on regulatory and compliance knowledge and provide independent quality support to project teams.
• Audit internal quality system elements in manufacturing and operational support areas.
• Provide oversight for compliance of Change Controls, CA/PA and investigations, OOS and deviations.
• Perform external audits of suppliers/vendors/off-site facilities. Act as a customer interface during on-site audits, conference calls and other standard means of communication.
• Independently identify and manage special projects or QA compliance functions as agreed upon with QA management.
• Prioritize and manage a variety of projects simultaneously. May need to lead and direct the work of others. Review and approve validation documents.
• Review and Master Batch Records (MBR) and supporting documents. Perform review/release of batch records, as needed.

Experience:

• 3-5 Years Experience
• Direct QA commercial drug substance/drug product experience required or an equivalent amount of aseptic processing and cell therapy manufacturing experience.
• GMP compliance and Part 11 compliance knowledge preferred.
• Experience with oversight of aseptic processing and the associated international aseptic processing regulations.
• Excellent written and oral communication to include accurate and legible documentation skills; ability to work in a fast paced environment; team oriented; independent work skills and a strong work ethic.