drjobs Lead Manufacturing Quality Investigator

Lead Manufacturing Quality Investigator

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Job Location drjobs

Baltimore, MD - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Job Description

Job Title: Lead Manufacturing Quality Investigator

Location: Baltimore MD

Duration: 56 Months

Responsibilities:

  • Initiate and/or evaluate deviations within the Quality Management System (QMS).
  • Interview personnel involved to gather relevant information.
  • Analyze root causes of deviations to assess impact on processes and products.
  • Identify corrective and preventive actions (CAPA) based on investigation findings.
  • Present root cause analyses and CAPA proposals to management for approval.
  • Own and author deviations ensuring documentation is accurate and timely.
  • Drive continuous improvement efforts within the Quality Management System.
  • Oversee both minor and major investigations ensuring proper resolution.
  • Ensure investigations are closed within established timelines and regulatory compliance.
  • Experience in Cell/Gene Therapy and Biologics Manufacturing is preferred.

Employment Type

Full Time

Company Industry

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