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Quality Assurance Associate

Location: Long Island, New York Salary: competitive
Sector: Pharma & Biotech, Medical Devices, Food and FMCG, Quality & Supply Chain, Quality Assurance (QA), Quality Assurance (QA), Operations and Production Type: Contract

I am partnering with a Pharmaceutical organizaton based in Long Island to secure a Quality Assurance Specialist - Investigations on an initial 6 month temp-to-hire basis. This role pays $30-$45 an hour maximum depending on experience.

The Quality Assurance Associate - 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 Chemistry or a related field.

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
  • Ideally a Chemistry or related background
  • CAPA experience (preferred)
  • Knowledge of TrackWise is a must
  • Industry experience in Six Sigma or a recognized troubleshooting / root cause analysis program.

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