QA Project Leader: Microbiology & Sterility Assurance

Fresenius Kabi; Melrose Park (IL); On-site; USD 90,000 - 110,000; Full time

Benefits offered by this job

401(k) with company contributions

Medical, dental, and vision coverage

Paid vacation and holidays

Job summary

Fresenius Kabi in Melrose Park, IL seeks a QA/QC Project Manager to drive compliance programs and continuous improvement within manufacturing. You will oversee investigations, CAPAs, and quality systems to ensure product quality and regulatory readiness.

The role emphasizes leading cross-functional teams, coordinating corrective actions, and supporting FDA/GMP inspections to maintain high quality standards in finished product release.

Qualifications

• Bachelor degree in science required with 3+ years of QA/QC experience in pharma or related regulatory industry.
• Experience with cGMP, GLP, ISO requirements preferred.
• Proven ability to author and review SOPs, work instructions, and risk assessments (e.g. FMEA).

Responsibilities

• PMO for QA/compliance projects and continuous improvement initiatives.
• Oversee deviation reduction, BRFT improvements and batch release cycle time (CRT).
• Consolidate quality metrics and prepare reports for senior management.
• Lead cross-functional meetings and provide technical leadership on sterility and microbiology.
• Support regulatory inspections and audits as information scribe or liaison.

Skills

Project management

QA/QC experience

cGMP knowledge

FMEA

SOP writing

Risk assessment

Education

Bachelor's degree in science

Tools

MS Office

Quality systems

Job description

Fresenius Kabi in Melrose Park, IL seeks a QA/QC Project Manager to drive compliance programs and continuous improvement within manufacturing. You will oversee investigations, CAPAs, and quality systems to ensure product quality and regulatory readiness.

The role emphasizes leading cross-functional teams, coordinating corrective actions, and supporting FDA/GMP inspections to maintain high quality standards in finished product release.