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AptarGroup, Inc. Quality Assurance Manager, Injectables in Congers, New York

Management and coordination of Quality Assurance activities; Responsible to manage project action plans, validation achievements for projects and routine revalidation for Injectable, ensure compliance to timelines for quality deliverables; Oversee the site knowledge transfer, including Quality Control Laboratory readiness to support the expansion; Manage risk analysis, change controls, and guide customer communication channels; Evaluate and lead resolution of product and process quality concerns, while ensuring equivalence to output and trends from other Aptar sites; Manage design transfer to operations along with key project management stakeholders; Ensures compliance with cGMPs, FDA requirements, and internal procedures.Requires: High school diploma, 2 months of vocational training as Quality Technician, and 1 year of experience in the job offered or as Validation Lead in medical devices/components company using ISO 15378 & cGMP.

Minimum Salary: 73,507 Maximum Salary: 172,500 Salary Unit: Yearly

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