Quality Assurance Specialist II

Job description

Our Work Matters At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. The Impact You Will Make The QA Specialist II provides advanced quality oversight and exercises judgment in product disposition, investigations, and change control. This role applies specialized knowledge to resolve quality issues, lead investigations, and ensure timely product release. QA Specialist II partners with cross-functional teams to implement improvements and maintain compliance with regulatory standards. Role Responsibilities: - Evaluate and approve batch documentation and exercise judgment in determining product disposition based on compliance standards. - Provide quality oversight and guidance for manufacturing and testing activities, including shop floor support, inspection readiness walk-throughs, line clearance, in-process checks, deviation and laboratory investigations, change management, SOP revisions, and batch documentation review. - Independently identify and resolve non-conformances in manufacturing operations; recommend corrective and preventive actions to management. - Perform timely reviews and make informed decisions on batch a...