Quality Associate

Fusion Life Sciences Technologies LLC; Round Lake (IL); On-site; USD 42,000 - 68,000; Full time

Job summary

Fusion Life Sciences Technologies LLC in Illinois is seeking a QC Microbiology Laboratory Support to perform microbiological testing, environmental monitoring, and laboratory support activities at a pharmaceutical manufacturing facility.

You will operate autoclaves, pH meters, and air samplers; maintain accurate data in the LIMS; support investigations and CAPA; and ensure compliance with cGMP, FDA requirements, data integrity standards.

Qualifications

• Bachelor's degree in Microbiology, Biology, or a related biological science.
• Minimum 2 years of laboratory experience.
• Basic microbiology knowledge and aseptic technique.
• Experience with LIMS or laboratory data management systems.
• Strong documentation and attention to detail.
• Ability to work onsite, including weekends and occasional holidays.
• Ability to lift up to 50 lbs when required.

Responsibilities

• Perform microbiological testing on raw materials, in-process samples, and finished products.
• Conduct environmental monitoring of air, surfaces, and personnel.
• Monitor critical utilities, including water, clean steam, compressed air, and nitrogen.
• Prepare laboratory media and reagents.
• Operate laboratory equipment, including autoclaves, pH meters, particle counters, and air samplers.
• Record and maintain accurate laboratory data using LIMS.
• Support laboratory investigations, root cause analysis, and CAPA.
• Follow cGMP, FDA requirements, SOPs, and data integrity standards.

Skills

Aseptic technique

Documentation accuracy

Onsite weekend work

Physical ability to lift 50 lbs

LIMS data management

Education

Bachelor's degree in Microbiology or related biological science

Tools

LIMS

Job description

Job Opportunity: QC Microbiology Laboratory Support

Work Arrangement: Onsite Only

Shift: 8:00 AM - 5:00 PM, Thursday-Monday

Job Summary

Seeking a QC Microbiology Laboratory Support professional to perform microbiological testing, environmental monitoring, and laboratory support activities at a pharmaceutical manufacturing facility.

Key Responsibilities

• Perform microbiological testing on raw materials, in-process samples, and finished products.
• Conduct environmental monitoring of air, surfaces, and personnel.
• Monitor critical utilities, including water, clean steam, compressed air, and nitrogen.
• Prepare laboratory media and reagents.
• Operate laboratory equipment, including autoclaves, pH meters, particle counters, and air samplers.
• Record and maintain accurate laboratory data using LIMS.
• Support laboratory investigations, root cause analysis, and CAPA.
• Follow cGMP, FDA requirements, SOPs, and data integrity standards.

Must-Have Qualifications

• Bachelor's degree in Microbiology, Biology, or a related biological science.
• Minimum 2 years of laboratory experience.
• Basic microbiology knowledge and aseptic technique.
• Experience with LIMS or laboratory data management systems.
• Strong documentation and attention to detail.
• Ability to work onsite, including weekends and occasional holidays.
• Ability to lift up to 50 lbs when required.

Preferred Skills

• Pharmaceutical or biotechnology laboratory experience.
• Environmental monitoring and microbiological testing.
• Knowledge of cGMP, GLP, root cause analysis, and CAPA.
• Work schedule: Thursday-Monday, including weekends and occasional holidays.
• Showering required when leaving the facility.
• Work may involve both Drug Delivery and Penicillin facilities. Allergy and exposure-related safety requirements must be reviewed with the site's occupational health or safety team before placement.