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Quality Assurance Specialist - Investigations

I am partnering with a Pharmaceutical organizaton based in Long Island to secure a Quality Assurance Specialist - Investigations on an initial 6 month contract but one which is likely to be extended.

The Quality Assurance Specialist - Investigations should have at least 3 years of experience in writing or assisting with investigations in the Life Science industry (Pharma, Biotech, Medical Device, Nutraceuticals, Food, Cosmetics etc) and have a technical background in either Microbiology, Production or Manufacturing.

Key Responsibilities:

  • Using root cause analysis techniques, assist the operations teams in and / or perform Deviation and investigation writing, OOS, OOS, OOT, field complaints, nonconformance and event excursions, and effective corrective/ preventative action implementation.
  • Develop and track CAPA plans.
  • Evaluate preventative maintenance (PM) requirements and work orders for critical equipment to determine (PM) effectiveness and potential predictive maintenance schedules.
  • Evaluate filling, packaging and compounding operations for effective and efficient operation.
  • Training of operations management personnel in performance of effective investigations.
  • Work daily in TrackWise.
  • Work closely with Quality Assurance in timely completion of deviations, investigations and CAPA's.

Key Experience Required:

  • 3+ years of Root Cause Analysis experience in an FDA Regulated industry
  • Microbiology, Production or Manufacturing background
  • CAPA experience (preferred)
  • Knowledge of TrackWise is essential
  • Industry experience in Six Sigma or a recognized troubleshooting / root cause analysis program.

Sthree US is acting as an Employment Business in relation to this vacancy.