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Sr Manufacturing Quality Manager

1 month ago

Parsippany, United States The Fountain Group Full time
Sr Manufacturing Quality Manager opening located in Parsippany, NJ. Details for the position are as follows:

Pay rate: $80.41/hr.

This is a hybrid role onsite Tue/Wed/Thu

Job Description/Responsibilities:

  • Lead and facilitate Quality Event Investigations and subsequent CAPA development in accordance with defined timelines and in collaboration with appropriate subject matter experts
  • Build, deploy and reinforce learning tools and materials to support quality event management capability development
  • Oversee the standard and timeliness of deviation and CAPA completion
  • Work with the business process owners to identify issues and improvement requirements and lead those improvement initiatives
  • In support of the quality management system module leads maintain records of issues, enhancement requests and support the implementation of system changes
  • Administer notification to management and escalation process
  • Participate in risk assessments and act as risk facilitator

Qualifications:
  • Bachelor s Degree
  • GxP experience is preferred
  • 10+ years experience in Biopharma experience
  • 6+ years managing investigations (deviations, CAPA, etc.)
  • Experience writing investigations
  • Experience managing RCA

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