Quality Assurance Manager, Injectables

NOTICE OF FILING

 

TITLE: Quality Assurance Manager, Injectables

 

DUTIES: 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.

 

SALARY: Wage range: $73,507 - $172,500 yearly.

 

SCHEDULE: 40 hours per week, Monday through Friday (9:00am-5:00pm)

 

LOCATION: 250 North Route 303, Congers, NY 10920

 

REQUIREMENTS: 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.

 

CONTACT: Sydney White, AptarGroup, Inc., 265 Exchange Drive, Suite 100, Crystal Lake, IL 60014.

 

This notice is provided in compliance with 20 CFR 656.10(d) as a result of the filing of an application for permanent alien labor certification for the job opportunity described above. Any person may provide documentary evidence bearing on the application to the Certifying Officer of the U.S. Department of Labor at the address below.

 

U.S. Department of Labor Employment and Training Administration Office of Foreign Labor Certification

200 Constitution Avenue NW, Room N-5311 Washington, DC 20210