QA Project Leader – Microbiology & Sterility Assurance

RXinsider LTD.; Melrose Park (IL); On-site; USD 90,000 - 110,000; Full time

Benefits offered by this job

Medical insurance

Dental coverage

Vision coverage

Life Insurance

Disability

401(k) with company contribution

Wellness program

Job summary

Fresenius Kabi in Illinois seeks a QA/QA lead to manage compliance programs and drive continuous improvement across quality systems. The role supports GMP compliance, investigations, and batch release processes.

Collaborating with the Sr. Director, Quality Assurance, you will oversee deviations, CAPAs, and regulatory interactions while striving to reduce defects and improve product quality and efficiency.

Qualifications

• Bachelor's degree in science and at least 3+ years in QA/QC within pharma or related regulatory industry.
• Experience with cGMP and GLP environments and ISO requirements.
• Knowledge of cleanroom operations, aseptic processing, and quality systems documentation.

Responsibilities

• Provide project management for compliance topics and continuous improvement in quality systems.
• Oversee investigations, CAPAs, deviation management, and batch release considerations.
• Prepare progress reports for senior management and support regulatory inspections.

Skills

Microbiology

Aseptic processing

Contamination control strategies

SOPs & risk assessments

Aseptic Process Simulations

Isolator technology

Cross-functional leadership

Education

Bachelor's degree in science

Job description

Fresenius Kabi in Illinois seeks a QA/QA lead to manage compliance programs and drive continuous improvement across quality systems. The role supports GMP compliance, investigations, and batch release processes.

Collaborating with the Sr. Director, Quality Assurance, you will oversee deviations, CAPAs, and regulatory interactions while striving to reduce defects and improve product quality and efficiency.