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Quality Assurance Specialist - Investigations

Location: Amityville, New York Salary: competitive
Sector: Pharma & Biotech, Medical Devices, Food and FMCG, Quality & Supply Chain, Quality Assurance (QA), Quality Assurance (QA), Technical and Quality Assurance 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 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 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 essential
  • Industry experience in Six Sigma or a recognized troubleshooting / root cause analysis program.

If this is something that could be of interest to yourself, apply ASAP as interviews are happening early next week.

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