Quality Assurance Specialist

2 days ago


Chicago, Illinois, United States Kelly Science, Engineering, Technology & Telecom Full time
Quality Assurance Associate Job Description

We are seeking a detail-oriented Quality Assurance Associate to join our specialty lab team in Gurnee, IL. This full-time position offers a comprehensive benefits package, including medical, dental, 401K, paid time off, and eligibility for annual performance reviews.

Key Responsibilities:
  • Quality Documentation: Draft and update quality documentation to ensure compliance with GMP standards.
  • Document Control: Maintain and control document approval, distribution, and review processes.
  • Internal Audits: Conduct comprehensive internal audits to identify non-compliance areas and document findings, outlining corrective actions.
  • Supplier Management: Ensure suppliers complete required questionnaires and adhere to compliance standards.
  • Training Development: Create training curricula for Standard Operating Procedures (SOPs) and policies, ensuring training is completed and documented in the training management system.
  • Mock Recalls: Perform and document mock recalls to assess organizational readiness and effectiveness.
  • Customer Complaints: Investigate and document customer complaints to resolve backlog issues effectively.
Requirements:
  • Education: Bachelor's degree in quality assurance, Life Sciences (Biology, Chemistry, Biochemistry, etc.), Engineering, or a related field. Master's degree preferred.
  • Experience: 3-5 years of experience in Quality Assurance within a GMP-regulated industry (pharmaceutical, biotechnology, or medical device).
  • Skills: Strong understanding of GMP, FDA regulations, and ISO standards. Proficiency with electronic quality management systems (eQMS) and training management systems.


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