NPI QA Specialist - 12 month FTC
Core
Ensuring new product integration into the AbbVie quality system and supporting transfers from development through commercialization.
Role type
Senior NPI Compliance Specialist
Builds
New product transfers and quality compliance for pharmaceutical projects
Domain
Healthcare / Pharmaceutical
Required skills
Regulatory compliance, Quality system management, Analytical test method transfer, Vendor evaluation, Corrective and preventative action (CAPA), Quality documentation, Quality metrics, Audit support
Preferred skills
QP eligibility
Technologies
None stated
Responsibilities
Implement and maintain NPI integration into the quality system, Support review and approval of analytical test method transfers, Manage technical agreements, Coordinate site review of material specifications, Generate quality project documentation, Support internal and external audits, Lead and support site quality projects, Track and trend quality projects, Coordinate management reviews and presentations
Seniority
Senior, hands-on IC
