Quality Assurance Manager

4 days ago

Lawrence, Kansas, United States Scismic Inc Full time
Job Description

Job Summary:

Scismic Inc is seeking a highly skilled Quality Assurance Manager to join our team. As a key member of our organization, you will be responsible for providing comprehensive technical support and quality assurance oversight to ensure compliance with good business practices and regulatory requirements.

Key Responsibilities:

  • Establish and Maintain Quality Management System: Develop, implement, and maintain a quality management system that meets regulatory requirements and industry standards.
  • Regulatory Compliance: Ensure compliance with FDA regulations, including 21 CFR Parts 210, 211, and 820, and other relevant regulatory agencies.
  • Quality Process Monitoring: Monitor quality processes and collect metrics to document performance and identify areas for improvement.
  • Collaboration and Communication: Work closely with cross-functional teams, including manufacturing, to ensure quality requirements are met and regulatory compliance is maintained.
  • Project Management: Participate in and lead project teams as a quality representative, ensuring quality requirements are met and regulatory compliance is maintained.
  • Training and Development: Train staff as needed to ensure quality awareness and compliance.
  • Continuous Improvement: Identify areas for improvement and implement initiatives to enhance quality and regulatory compliance.

Requirements:

  • Education: Bachelor's degree in Life Science (Biology or Biochemistry) or equivalent.
  • Experience: Minimum 6 years of pharmaceutical experience, with a minimum of 6 years in quality assurance management.
  • Skills: Extensive knowledge of FDA regulatory requirements, technical knowledge of pharmaceutical manufacturing, validation, raw materials, analytical testing, and materials management.
  • Abilities: Excellent communication skills, verbal and written, ability to manage multiple activities, and demonstrated ability to work effectively in a customer service and business partner role.

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