QA Specialist II - 2nd Shift

Company: The Fountain Group LLC
Location: Buffalo Grove
Posted on: May 28, 2023

Job Description:

Long Term Contract
Pay Range: $25-29/hour
2nd shift - 12 PM TO 8:30 PM MONDAY THRU FRIDAY
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Assist with administration and ensuring compliance to Quality Management Systems including:

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• Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
  
• Lead the investigation, resolution and prevention of product and process nonconformances.
  
• Actively monitors Third Party Manufacturers data and Support areas for compliance with internal Standard Operating Procedures (SOPs) and relevant regulatory (cGMP, ISO) regulations.
  
• Reviews GMP related documentation for compliance such as batch records and associated data related to product manufacturing, testing and release, validation protocols and reports, labels, product specifications and other documentation as required.
  
• Participates in Corrective Action/Preventive Action (CAPA) process including the investigation of failures or deviations in the Manufacturing area as required.
  
• Writes and revises SOPs, controlled forms, and related documents to ensure best practices and alignment with current operations.
  
• Collaborates with members of the Quality Assurance team working on special projects.
  
• Participate on permanent and temporary teams which are process or project driven.
  
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  
• Collect, analyze, and publish quality metrics.
  
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  Qualifications
  
  
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  • 2-6+ years of relevant work experience.
    
  • FDA/GMP regulated experience is a plus.
    

Keywords: The Fountain Group LLC, Buffalo Grove , QA Specialist II - 2nd Shift, Other , Buffalo Grove, Illinois