Biocompatibility Project Coordinator

301055 Fenwal, Inc.; Lake Zurich (IL); Vor Ort; USD 75.000 - 80.000; Vollzeit

Benefits dieser Stelle

401(k) plan with company contributions

Paid vacation, holiday and personal/pd

Employee assistance program

Health benefits: medical, prescription

Dental and vision coverage

Zusammenfassung

Fresenius Kabi USA Lake Zurich seeks an Associate Project Manager to support biocompatibility and material qualification activities for the Transfusion and Cell Therapies business. You will coordinate outsourced studies, manage protocols and reports, and help ensure compliant execution of testing.

Under guidance of a Senior PM and SME, you will handle documentation, risk assessments, supplier coordination, and maintain the qualification database.

Qualifikationen

• Bachelor’s degree in chemistry, biology, or related discipline required.
• Minimum 3 years of experience in a related role.
• 1 year of project management experience preferred.
• Familiarity with ISO 10993-1 and related parts incl. USP <87>, <88>.
• Advanced knowledge of Office (Outlook, Word, Excel, PowerPoint).

Aufgaben

• Coordinate Fresenius Kabi Lake Zurich biocompatibility program for material qualification.
• Prepare, review and approve protocols and reports for materials testing.
• Support testing programs through risk assessment and documentation.
• Identify risks and develop response strategies.
• Coordinate with CROs and manage supplier quality audits.
• Ensure conformance to 21 CFR Part 58 (GLP) and related regulations.
• Maintain the qualification database and archive study documentation.

Kenntnisse

Project coordination

Biocompatibility

Documentation management

Communication skills

ISO knowledge

MS Office

Ausbildung

Bachelor's degree in chemistry or biology

Tools

Microsoft Office

LIMS

Jobbeschreibung

Fresenius Kabi USA Lake Zurich seeks an Associate Project Manager to support biocompatibility and material qualification activities for the Transfusion and Cell Therapies business. You will coordinate outsourced studies, manage protocols and reports, and help ensure compliant execution of testing.

Under guidance of a Senior PM and SME, you will handle documentation, risk assessments, supplier coordination, and maintain the qualification database.