Quality Compliance Specialist

Planet Pharma • novato, ca, us • 1m ago

Duties:

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

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