Job Description :

Manager, Quality Assurance in Rensselaer, NY
Client  provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. 
The Manager of Quality Assurance is an integral part of the team, contributing to our success by providing professional expertise and leadership in the Quality function.  As the Manager you will be responsible, along with the Head of Quality Assurance, for ensuring that all manufactured materials are in accordance with the Company's quality assurance program and quality/reliability standards to satisfy cGMP regulatory requirements and customer specifications and expectations.
Qualifications and background to be successful in this role: 

  • Minimum Bachelor of Science in Chemistry or a related field 
  • Minimum 5 years' QA, RA experience in pharmaceuticals or a related cGMP regulated industry 
  • Minimum 2 years supervisory experience or coach/mentor role 
  • Broad knowledge of cGMP, FDA and international regulations (e.g., 21 CFR 11, EU GMP, ICH Q7), Quality Systems for active pharmaceutical ingredients (APIs), and familiarity with guidelines (e.g., FDA, ICH). 
  • Knowledge of pharmaceutical processes to be able to make appropriate decisions. 
  • Strong attention to detail is required. 
  • Strong interpersonal, written and oral communication skills. 
  • Excellent communication and collaboration skills and demonstrated ability to work cross functionally across internal stakeholders.

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