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Quality Investigation Specialist

APP Consultants New Brunswick Full-Time
$75,000.00 - $85,000.00 / year
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By using Root Cause analysis training and process improvement skills, assist operations management in evaluation to improve the production, packaging, engineering processes at the Somerset plant by implementing projects that result in prevention and reduction of repeated excursions. Write department investigations for production, mechanical support, facilities and engineering. Establish meaningful CAPA’s and track CAPA’s for timely completion. Knowledge of TrackWise is essential.

ESSENTIAL FUNCTIONS:

  • 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.

Qualifications

  • Bachelor of Science in a Quality / Process related field.
  • Industry experience in Six Sigma or a recognized troubleshooting / root cause analysis program.
  • Minimum of 3 years of root cause analysis experience in a manufacturing or packaging environment, preferably pharmaceutical or FDA regulated operation.
  • Experience in aseptic or clean room environment highly preferred

·      

Skills required

Good Manufacturing Practices
Operations
Manufacturing
Product Quality Assurance
Technical Services
Raw Materials
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