Senior QC Microbiology Leader – Sterility & Compliance

Tailstorm-Health-Inc; Chandler (AZ); On-site; USD 120,000 - 125,000; Full time

Job summary

Tailstorm-Health-Inc in Chandler, AZ is seeking an Associate Director of QC Microbiology to lead the QC Microbiology function for sterile injectable manufacturing. You will oversee microbiological testing, environmental monitoring, contamination control, sterility assurance, investigations, laboratory operations, and regulatory compliance to ensure product quality and patient safety.

The role serves as site microbiology SME and supports aseptic processing, contamination control strategy, and

Qualifications

• Bachelor's degree in Microbiology, Biology, Pharmaceutical Sciences, or related field.
• 10+ years of microbiology experience in sterile pharmaceutical manufacturing.
• 5+ years of leadership experience in QC Microbiology.
• Strong expertise in environmental monitoring, aseptic processing, sterility assurance, and contamination control.
• Experience supporting FDA inspections and regulatory compliance activities.

Responsibilities

• Lead day-to-day QC Microbiology laboratory operations supporting sterile manufacturing.
• Manage staffing, training, performance, budgets, laboratory inventory, and equipment.
• Develop and mentor microbiology personnel while ensuring operational excellence.
• Oversee sterility, endotoxin, bioburden, microbial limits, and antimicrobial effectiveness testing.
• Manage microbial identification programs, isolate libraries, reference cultures, and media qualification activities.
• Ensure compliance with USP and regulatory requirements.
• Lead environmental monitoring programs for classified manufacturing areas.
• Establish sampling plans, alert/action limits, and trend analysis programs.
• Oversee microbiological monitoring of WFI, purified water, clean steam, and process gases.
• Own and maintain the site Contamination Control Strategy.
• Lead media fills, aseptic process support, cleanroom qualifications, and sterilization validation activities.
• Oversee disinfectant efficacy studies, cleaning programs, and contamination control initiatives.
• Lead investigations involving EM excursions, sterility positives, endotoxin OOS results, and contamination events.
• Perform root cause analysis, risk assessments, and CAPA development.
• Support deviations, change controls, and quality system activities.
• Develop and deliver aseptic technique, gowning, and contamination control training.
• Conduct routine observations of aseptic operations and drive continuous improvement.
• Maintain personnel qualification and requalification programs.
• Serve as microbiology SME during FDA inspections, audits, and customer assessments.
• Author and approve SOPs, protocols, reports, investigations, and trend analyses.
• Ensure data integrity, Part 11 compliance, and ongoing inspection readiness.

Skills

Leadership

Environmental monitoring

Sterility assurance

Regulatory compliance

FDA inspections

Education

Bachelor's degree in Microbiology or related field

Master's degree (preferred)

Job description

Tailstorm-Health-Inc in Chandler, AZ is seeking an Associate Director of QC Microbiology to lead the QC Microbiology function for sterile injectable manufacturing. You will oversee microbiological testing, environmental monitoring, contamination control, sterility assurance, investigations, laboratory operations, and regulatory compliance to ensure product quality and patient safety.

The role serves as site microbiology SME and supports aseptic processing, contamination control strategy, and