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Microbiology Manager

Indianapolis $125,000 - $145,000 Permanent

Responsibilities

  • Lead day-to-day operations of QC Microbiology and Environmental Monitoring laboratories
  • Oversee testing of raw materials, in-process samples, finished products, and stability batches under GMP conditions
  • Approve test methods, specifications, sampling plans, and quality procedures
  • Manage and assess contract testing labs to ensure compliance and quality standards
  • Ensure timely review and approval of lab data and documentation prior to QA handoff
  • Oversee validation and qualification of lab methods, equipment, and processes
  • Promote clear communication, accountability, and collaboration across departments
  • Build and develop a high-performing team through coaching, feedback, and performance management
  • Align team objectives with site strategy and monitor progress through KPIs
  • Enforce safety practices and ensure compliance with ALARA principles and regulatory requirements
  • Drive continuous improvement, lean initiatives, and lab efficiency
  • Maintain clean, organized lab spaces in accordance with 5S and inspection readiness standards
  • Lead or support quality investigations, CAPAs, and deviations within QC scope
  • Review and update SOPs and controlled documents to reflect current practices
  • Identify and act on opportunities to improve quality, reduce risk, and optimize workflows

Qualifications

  • Bachelor’s degree in a scientific discipline or equivalent experience required
  • 10 years of experience in pharmaceutical quality control or microbiology
  • Minimum 2 years in a leadership or managerial role
  • Deep knowledge of cGMP regulations and regulatory guidelines (FDA, EU, ISO, USP)
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