• Support Quality Compliance processes including inspection readiness, self-inspection program, data integrity initiatives, and regulatory certification activities
• Support or lead continuous improvement in quality systems (procedures and systems) to improve organizational effectiveness, quality assurance compliance, and regulatory and other requirements (cGMP, ICH).
• Adhere and follow cGMPs guidelines and procedures. Escalate non-compliance concerns to management.
• Interface with other departments (Manufacturing, Quality Control, Technical Development, Quality Assurance, etc.) and contractors as necessary
• Interpret and apply 21CFR, USP, EP, JP and ICH regulatory guidelines and directives
• Other duties as assigned

Requirements:

• BS/BA in a scientific discipline or related field and 4-6 years in a biologics manufacturing environment
• Prior experience in Manufacturing, Quality Control, and Quality Management System (QMS) processes
• Excellent written, verbal, analytical, and interpersonal skills