Quality Specialist

• Provide quality assurance support and oversight for external Synthetic manufacturing operations, including commercial manufacturing, packaging, testing, release, stability and related supply activities
• Review, coordinate and provide quality concurrence or approval for deviations, non-conformances, investigations, CAPAs, change controls, complaints, product disposition records, manufacturing instructions, specifications, validation documentation, technical studies and quality agreements
• Monitor quality and compliance performance of assigned external manufacturers using quality metrics, risk ratings, audit outcomes, inspection history, supplier performance data and issue trends
• Identify, communicate and escalate quality, compliance or supply risks and support risk-based mitigation and remediation plans
• Support qualification, ongoing monitoring and lifecycle management of external manufacturers and strategic partners
• Collaborate with External Quality Site Leads, Product Quality, MSAT, Planning, Procurement, Regulatory, EHS, Qualified Persons and external partners
• Support external manufacturers during J&J audits, health authority inspections and regulatory commitments
• Participate in technology transfer, new product introduction, product lifecycle management, process improvement and risk management initiatives
• Contribute to continuous improvement of External Quality processes, documentation practices, quality culture and performance management

Explore Senior Specialist, External Quality at Johnson & Johnson. Review requirements and application details.