Quality Assurance Specialist

4 hours ago


Columbia, Missouri, United States LanceSoft, Inc. Full time

Job Title: Quality Assurance Specialist

Job Summary:

We are seeking a highly skilled Quality Assurance Specialist to join our team at LanceSoft, Inc. The ideal candidate will have a strong background in quality assurance and a passion for ensuring the highest standards of quality in our products.

Key Responsibilities:

  • Provide oversight of the QA floor program and supervision of processes and personnel.
  • Ensure staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines.
  • Provide QA oversight, technical expertise and leadership across all aspects of product manufacturing and operations support.
  • Ensure manufacturing compliance with applicable procedures and batch records.
  • Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.

Requirements:

  • Masters' degree in a Scientific, Engineering or Biotech field with 4+ years' experience in Quality Assurance/ Quality Control/ Manufacturing within biologics, biopharmaceuticals, or a regulated industry.
  • Familiarity with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs.
  • Familiarity with electronic systems, including developing and producing reports using Microsoft products.


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