Quality Assurance Specialist

3 months ago


Harmans, United States LanceSoft, Inc. Full time

This position is responsible for authoring, reviewing, and approving deviations and non-conformances within a biologics manufacturing setting. Strong experience in upstream processes and/or cell/gene therapy.


Key Responsibilities:

  • Deviation and Investigation Writing: Draft 5-7 minor deviations per week with 5-6 approved, or 3-5 major deviations weekly.
  • Unit Operations Expertise: Including cell culture, bioreactors, TFF, chromatography, and filtrations.
  • Single-Use Disposable Systems: Experience with these systems.
  • Root Cause Analysis (RCA): Familiarity with 5 Whys, 6Ms, and fishbone diagrams.
  • TrackWise System: Experience with TrackWise or similar systems.


Must-Have Qualifications:

  • Upstream and/or Cell/Gene Therapy Experience
  • Proven Experience in Authoring Deviations/Investigations
  • Strong Biologics Experience
  • Familiarity with cGMP Manufacturing Environments
  • Strong Writing Skills
  • Life Science or Engineering Degree with at least 5 years of relevant experience


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