Senior Quality Assurance Specialist

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 Senior QA Specialist provides strategic quality oversight and leads projects that enhance compliance and operational efficiency. This role manages investigations, change control, and product release while driving continuous improvement initiatives. The Senior QA Specialist collaborates across functions to influence quality systems and ensure alignment with regulatory requirements. Role Responsibilities: - Lead and approve complex document reviews to ensure manufacturing and testing processes comply with approved batch/testing records, SOPs, and cGMP standards. - Provide strategic QA 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, resolve, and influence corrective actions for non-conformances in manufacturing operations; drive systemic improvements to prevent recurrence. - Perf...