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Quality Manager

2 months ago

Lawrence, Kansas, United States MRINetwork Jobs Full time
Job Summary

We are seeking a highly experienced Quality Manager to join our team at MRINetwork Jobs. The successful candidate will be responsible for providing comprehensive technical support and quality assurance oversight to meet good business practices and the requirements of applicable Health Authorities.

Key Responsibilities
  • Supports the manufacturing, testing, disposition, and distribution of all materials that the company manufactures.
  • Ensures product(s) consistently meets our customer and regulatory requirements.
  • Responsible for the overall development, implementation, maintenance, and performance of the quality system.
  • Works with other departments to ensure progress toward company goals while maintaining compliance with QSR requirements.
  • Monitors quality processes and collects metrics to document performance.
Requirements
  • Bachelor's Degree
  • Min. 6 years of Quality experience in FDA regulated Pharma or Medical Devices
  • Min. 3 years of Quality Management experience
  • Excellent people, communication and management skills to create a team environment
  • Good leadership skills to motivate plant personnel and gain their respect
  • Working knowledge of 21 CFR Parts 210, 211 and 820 FDA compliance
  • Skills in Quality Management, Staffing, Management Proficiency, Coordination, Coaching, Developing Standards, Quality systems Improvement, Decision Making, Strategic Planning, etc.
  • Technical knowledge of pharmaceutical manufacturing, validation, raw materials, analytical testing, and materials management is desirable.
  • Able to work effectively in a customer service and business partner role.
Preferred Qualifications
  • Technical degree in Science, Chemistry, Biology, Microbiology or Engineering
  • Certified Quality Auditor certification, or equivalent.
  • Experience with remediation of Quality systems in FDA 483, warning letter, or Consent Decree.
  • Audit or inspection experience preferred.
  • Startup or Small company experience working in a dynamic and hands-on role.
  • Familiarity with Microsoft Project and project management principles.
  • Knowledge of Sterile Aseptic Filling Operations
  • Contract Manufacturing experience working closely with customers and clients