Quality Compliance Associate

• 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 client 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

• Prior experience in Manufacturing, Quality Control, and Quality Management System (QMS) processes
• Excellent written, verbal, analytical, and interpersonal skills.

• BS/BA in a scientific discipline or related field and 4-6 years in a biologics manufacturing environment.

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