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Quality Assurance Manager

Date: Oct 14, 2020

Location: Congers, NY, US

Company: Aptar Group

Quality Assurance Manager

Create, Innovate, Deliver Solutions!  Aptar Pharma NA is seeking a Quality Assurance Manager within our Quality team. Aptar Pharma is part of Aptar Group, a global leader with decades of success in the development of health dispensing solutions. Aptar Pharma has been setting the standard for drug delivery medical devices and we continue to break new ground providing innovative devices, components and services that enable the success of our clients and improve the health of patients. If you are curious, enjoy challenges and a fast-paced environment, we are the next step in your career!

The Quality Assurance Manager leads our Quality Assurance activities, ensuring quality goals and objectives are met.  

What You Will Do at Aptar Pharma:

  • Set standards for site-wide Quality Systems. Responsible for ISO Management Review.
  • Oversee Quality Systems process performance (including Document Control, Change Control, CAPA, FMEA, and ISO certifications)
  • Manage the process performance of batch release for Rx/CHC materials in compliance with customer, regulatory and our overall manufacturing requirements.
  • Approve Certificates of Conformance (COC) / Certificates of Analysis (COA) & COC/COA templates.
  • Implement cGMP requirements and Continuous Improvements in Quality Operations.            
  • Review and approve customer complaint reports.                                                              
  • Review and approve customer specifications, review Quality Agreements.                  
  • Prepare reports by collecting, analyzing and summarizing information and trends.
  • Organize required training (internal and external) for staff.
  • Ensure that all safety rules and regulations are respected (OSHA, etc.).  Maintain and improve housekeeping in all areas.
  • Maintain individual skills keeping up to date with the latest quality management concepts.
  • Assign responsibilities, delegate authority, recruit, select, orient and train employees.
  • Maintain Quality performance level by coaching, counseling, disciplining employees, answering grievances, planning, monitoring, and appraising job results.

 

 

What Aptar Pharma Is Looking For:

  • Bachelor’s Degree preferably in life sciences (Chemistry, Biology).
  • Minimum 5 years’ experience in Manufacturing Medical Device, Biomedical or Pharmaceutical industries.
  • Minimum 5 years’ experience in ISO certified and/or FDA regulated manufacturing business.
  • Minimum 5 years’ Experience or strong proven understanding of managing Quality Systems.
  • Experience leading an audit program, customer interaction, managing projects.
  • Proven experience writing SOP’s.
  • Excellent understanding of Quality principles, industry practices, and standards with demonstrated ability to apply these to GMP operations at CMOs and Suppliers
  • Experience and knowledge of GMP, CFR 21 regulations, ISO standards ISO 15378 &/or ISO 13485
  • Strong analytical skills, flexible, and hands-on.                                                                                             
  • Experience delivering effective presentations and training programs..   
  • Excellent inter-personal skills, leadership and diplomacy, builds strong relationships
  • Detail oriented, rigorous, analytical, reactive, and good interpersonal skills.
  • Knowledge and experience with CAPA, quality risk management, FMEA and other key tools for managing quality performance a plus.
  • Self-Starter with effective organizational, written and communication skills. 

 

Aptar Pharma, Congers
250 Route 303 North
Congers, NY 10920

www.aptar.com

Create, Innovate, Deliver Solutions! 
Aptar is an Equal Employment Opportunity (EEO) employer. It is the policy of the Company to provide equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information

 


Nearest Major Market: New York City