Lead QC Microbiology, Aseptic Operations

Resilience; Northern (KY); Hybrid; USD 60,000 - 86,000; Full time

Job summary

Resilience is seeking an Analyst II, QC Micro – Aseptic, Lead to oversee environmental monitoring in sterile pharma manufacturing. You will self-direct EM scheduling, review data for trends, and drive investigations and process improvements, serving as the day-to-day link between QC Microbiology and Operations. A strong background in aseptic operations and cGMP is required.

Join a biotech manufacturing team focused on resilient, scalable solutions with competitive compensation and benefits.

Qualifications

• Sterile pharmaceutical QC experience and ability to self-direct
• Independently analyze EM data and identify trends
• Lead investigations and complex tasks with limited supervision
• Experience training others
• Coordinate daily activities of EM technicians

Responsibilities

• Maintain qualification to perform EM technician responsibilities including aseptic gowning
• Verify QC data and monitor for trends and abnormalities
• Review production documentation and logbooks for quality, completeness, and cGMP compliance
• Troubleshoot and develop EM methods and processes
• Lead and coordinate investigations and process improvement activities with limited supervision
• Schedule work and load pulls in the Environmental Monitoring System
• Coordinate workflow and assign tasks and activities within the Environmental Monitoring team
• Serve as the primary link between QC and Operations for scheduling and workload planning
• Train team members on systems, software, equipment, procedures, and processes
• Ensure the team has the tools and training needed to perform their work in compliance
• Fill in for the immediate supervisor as needed
• Perform other duties supporting Environmental Monitoring, Operations, or Laboratory processes

Skills

EM data analysis

Leadership

cGMP knowledge

Training others

Team coordination

Aseptic operations

Problem solving

Education

Bachelor’s degree

Tools

MODA

Novatek

Job description

Resilience is seeking an Analyst II, QC Micro – Aseptic, Lead to oversee environmental monitoring in sterile pharma manufacturing. You will self-direct EM scheduling, review data for trends, and drive investigations and process improvements, serving as the day-to-day link between QC Microbiology and Operations. A strong background in aseptic operations and cGMP is required.

Join a biotech manufacturing team focused on resilient, scalable solutions with competitive compensation and benefits.