Expert Witness

3 days ago

North Reading, Massachusetts, United States Aphios Corporation Full time

Job Summary

We are seeking an experienced Expert Witness specializing in Contaminant Assessment within FDA-regulated manufacturing environments. This role involves providing expert analysis, testimony, and consulting on contamination issues related to pharmaceutical, biotech, or medical device production. The ideal candidate will possess a deep understanding of FDA regulations, contamination control strategies, and quality assurance processes to support legal proceedings and regulatory investigations. This position offers an opportunity to contribute specialized knowledge to complex cases, ensuring compliance and safety standards are upheld.

Responsibilities

  • Analyze contamination incidents in FDA-regulated manufacturing facilities and prepare comprehensive reports.
  • Provide expert testimony and technical consultation during legal proceedings, regulatory audits, or investigations.
  • Review manufacturing processes, quality control data, and environmental monitoring records to identify root causes of contamination.
  • Collaborate with legal teams, regulatory agencies, and internal stakeholders to clarify technical findings.
  • Stay current with evolving FDA regulations, industry standards, and contamination control methodologies.
  • Assist in developing mitigation strategies and recommendations to prevent future contamination issues.
  • Document findings clearly and professionally for use in legal or regulatory contexts.

Skills

  • Extensive knowledge of FDA regulations related to pharmaceutical or medical device manufacturing (e.g., 21 CFR Part 211 or Part 820).
  • Proven experience in contamination assessment, microbiology, environmental monitoring, or quality assurance within regulated industries.
  • Strong analytical skills with the ability to interpret complex scientific data and manufacturing documentation.
  • Excellent written and verbal communication skills for effective testimony and report writing.
  • Ability to work independently with minimal supervision while managing multiple cases simultaneously.
  • Prior experience serving as an expert witness in legal or regulatory proceedings; advanced degree in microbiology, pharmaceutical sciences, or related field. This position is a vital role for ensuring compliance with FDA standards through expert analysis and testimony on contamination issues within manufacturing environments.

Ideal candidates may include former FDA investigators, QA/QC directors, process engineers, contamination-control specialists, or toxicologists with expert testimony experience.

Job Type: Contract

Pay: $ $43.41 per hour

Expected hours: 10 – 40 per week

Work Location: Hybrid remote in North Reading, Massachusetts 01864

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