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Senior Microbiology Manager

Indianapolis $100,000 - $115,000 Permanent

Job Responsibilities:


  • Oversee Quality Control laboratories, including Microbiology and Environmental Monitoring.
  • Ensure all required testing is performed accurately and on time.
  • Approve specifications, sampling instructions, test methods, procedures, and other QC-related protocols.
  • Manage and monitor contract testing laboratories for compliance and test results.
  • Ensure proper validation and qualification processes are completed and approved.
  • Review and approve laboratory records before submission to the QA department.
  • Coach and develop team members to foster ownership and responsibility within the group.
  • Ensure team compliance with company policies, procedures, and regulations.
  • Set clear goals aligned with site strategies and manage team performance effectively.
  • Demonstrate accountability in leading change, completing projects, and driving continuous improvement.
  • Provide leadership in employee relations through clear communication, coaching, and development to remove obstacles for team progress.
  • Enforce strict safety compliance and ensure safety meetings are regularly held.
  • Lead the team in continuous improvement initiatives.
  • Maintain cleanliness and proper maintenance of department facilities and equipment.
  • Track and communicate team progress against individual, team, and site Key Performance Indicators (KPIs).
  • Lead or support investigations, reviewing and approving area quality and safety reports, and ensuring timely completion of corrective actions.
  • Review and update controlled documents related to the area of responsibility.
  • Identify opportunities for risk reduction, cost savings, and service improvements.


Qualifications:


  • Bachelor's Degree in a scientific discipline or equivalent work experience.
  • 12+ years of relevant leadership experience in Quality Control, including 2+ years in management, preferably with teams of 10+ multi-shift employees.
  • Strong knowledge of aseptic cGMP requirements and laboratory equipment/product validation.
  • Hands-on experience in a pharmaceutical manufacturing facility, with a deep understanding of QC laboratory testing, analytical methods, and statistical quality control.
  • Expertise in the manufacturing and control of finished products.
  • Familiarity with FDA, EU, ISO, USP, and other regulatory testing guidelines, including analytical method validation.
  • Comprehensive understanding of quality systems.
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