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Intertwined

GMP Quality Investigation Analyst

Full Time
Alburtis, PA, USA
Description

The Denzel Group, an award-winning search firm, has been chosen to work with a global leader in the Lehigh Valley on their quest for a talented Quality Analyst to influence customer satisfaction in the GMP Pharma commercial packaging space. In this role you will be conducting/writing investigations, root cause analysis and working with CAPAs, regarding customer complaints and deviations. You will be collaborating internally, as well as communicating with the customer.


Responsibilities 

  • Interface with customer concerning complaints, events and deviations.

  • Author investigations and reports, and ensure accuracy of root cause determination.

  • Support CAPAs associated with reports.

  • Participate on Material Review Board regarding nonconformance reports.

  • Maintain system to capture and report key metrics (KPI’s).

  • Analyze data (failure modes, nonconformance reports, root cause, etc.) to identify trends and opportunities for improvement.  

  • Support internal/external audits.

Requirements
  • 1-7+ years’ (depending on degree) experience in a GMP manufacturing environment.

  • 2+ years of handling customer complaints.  

  • Strong experience conducting root cause investigations and technical writing.


Compensation: $50k - $80k


To apply please send your application to mschroeder@thedenzelgroup.com


#IND1


Analyst, technical writer, specialist, quality, QA, quality assurance, client, customer, package, GMP, FDA, ISO, complaint, investigation, RCA, root cause, deviation, nonconformance, capa

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