Quality Control - Biologist/Microbiology

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Position Brand Description

The EM associate assists in the safe, compliant execution of the environmental monitoring (EM) program for the Research Triangle Park Facility for Lilly production areas (a 24/7 operation). This role is responsible for process monitoring and improvement, issue resolution/investigation, EM data system steward, and acts as a liaison between EM and multiple areas in ownership and/or execution of improvements, projects, and change controls.

Key Objectives/Deliverables

• Ensure FUME and EM Programs meet or exceed agency guidelines.
• Provide technical guidance to Operations and other support areas regarding FUME and EM matters.
• Compile, review and approve FUME and EM evaluation reports and data review to support batch release.
• Provide technical support for FUME and EM initiatives involving viable, nonviable, personnel monitoring.
• Manage procedural revisions, if needed.
• Proactively drive FUME and EM projects that support operations, sterility assurance initiatives, and regulatory commitments.
• Perform root cause investigation of EM and/or FUME non-conformances.
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
  
  
  

Minimum Requirements

• Bachelor degree in microbiology or related science
• 3 years of experience in a GMP pharmaceutical laboratory
• Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
  
  
  

Additional Preferences

• Strong understanding of current internal and applicable external standards for FUME, EM and sterility assurance.
• Problem solving and decision-making skills, with emphasis on data-based decisions, and customer service.
• Strong technical writing skills and proficiency in technical review of documents.
• Experience (3 years) in Environmental Monitoring and/or Utilities Monitoring.
• Experience with MODA
• Experience with data trending and analysis.
• Experience with Root Cause Analysis
  
  
  

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