NPI QA Specialist - 12 month FTC
Core
Ensuring new product integration and transfers into the AbbVie quality system while meeting regulatory requirements and mitigating quality risks.
Role type
Senior NPI Compliance Specialist
Builds
New product transfers from development through commercialization
Domain
Pharmaceutical / Healthcare
Deliverable
client delivery
Required skills
Quality system implementation, regulatory compliance, analytical test method transfer support, vendor evaluation, corrective and preventative action (CAPA), quality metrics tracking, audit support
Preferred skills
QP eligibility
Technologies
None stated
Responsibilities
Implement and maintain NPI integration in the quality system, support review and approval of analytical test method transfers, manage technical agreements, coordinate site reviews of material specifications, generate quality project documentation, lead site quality projects, track and trend quality projects, support internal and external audits
Seniority
Senior, hands-on IC