Shionogi Inc. (U.S.)

QA Engineer

• Provide temporary QA support to maintain quality and compliance oversight of sterile pharmaceutical products manufactured by third-party partners.
• Review manufacturing and packaging batch records; escalate issues and perform final disposition of assigned products.
• Support and coordinate investigations (deviations, OOS/OOT, product complaints), initiate CAPAs, and ensure timely closure.
• Maintain ongoing communication with contract manufacturers to resolve quality issues, monitor compliance, and ensure product release readiness.
• Provide QA input during regulatory inspections and support documentation needs (change controls, stability protocols, technical agreements).
• Assist in ensuring that audit findings are tracked and CAPAs are effectively implemented.
• Collaborate with Supply Chain, Regulatory, and other partners to ensure continued product quality and supply continuity.
• Lead large-scale technology transfers.
• Build or negotiate new or existing quality agreements
• Provide support for Shionogi Developmental Products as needed

QA Product Manager, Sterile