Senior Microbiology Manager

Harba; Indianapolis (IN); On-site; USD 110,000 - 170,000; Full time

Job summary

Harba in Indianapolis, IN seeks a seasoned Quality Control Leader to oversee QC laboratories, including Microbiology and Environmental Monitoring, and to ensure testing accuracy and timeliness.

The role requires 12+ years in QC leadership, a Bachelor's degree in a scientific field, and strong knowledge of cGMP, regulatory guidelines (FDA/ISO), and methods validation. You will lead continuous improvement and mentor staff.

Qualifications

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

Responsibilities

• Oversee QC laboratories (Microbiology and Environmental Monitoring) and ensure testing accuracy and timeliness.
• Approve specifications, sampling instructions, test methods, procedures, and QC-related protocols.
• Manage and monitor contract testing laboratories for compliance and results.
• Ensure proper validation and qualification processes are completed and approved.
• Review and approve laboratory records before submission to QA.
• Coach and develop team members; drive ownership and accountability.

Skills

Leadership

Quality Control

cGMP

Analytical methods

Statistical quality control

Education

Bachelor's degree in a scientific field

Tools

Laboratory equipment

Job description

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.