QA Project Lead, Microbiology & Sterility Assurance

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

Benefits offered by this job

401(k) with company contributions

Health benefits (medical, dental, vis

Paid vacation, holidays and personal</

Job summary

Fresenius Kabi USA, LLC in Melrose Park, IL seeks a QA/QC Project Manager to support GMP compliance and continuous improvement. You will oversee investigations, CAPAs, and the final review of investigations to ensure product quality and timely corrective actions.

The role requires coordinating with QA and operations, tracking project progress, and presenting reports to senior management. A science degree with 3+ years in pharma QA/QC is expected.

Qualifications

• Bachelor degree in science with 3+ years QA/QC in pharma.
• Advanced training in cGMP, GLP, ISO requirements.
• English proficiency required for policy and training materials.

Responsibilities

• Collaborate with senior QA leadership to manage quality systems.
• Oversee investigations for product quality and CAPAs.
• Lead projects focused on compliance and continuous improvement.
• Track progress, deliver progress reports, and escalate issues.
• Participate in regulatory inspections and audits as needed.
• Contribute to deviation reduction and batch release timelines.

Skills

Microbiology

Aseptic Processing

Contamination Control

SOPs & Risk Assessments

Media Fills

Isolator Technology

GMP Compliance

Education

Bachelor degree in science

Job description

Fresenius Kabi USA, LLC in Melrose Park, IL seeks a QA/QC Project Manager to support GMP compliance and continuous improvement. You will oversee investigations, CAPAs, and the final review of investigations to ensure product quality and timely corrective actions.

The role requires coordinating with QA and operations, tracking project progress, and presenting reports to senior management. A science degree with 3+ years in pharma QA/QC is expected.