Chemistry & Stability Lead - Quality & Compliance

Fresenius Kabi USA; North Carolina; Vor Ort; USD 74.000 - 104.000; Vollzeit

Benefits dieser Stelle

401(k) plan with company contributions

Health benefits (medical, dental, vis*

Paid vacation

Wellness program

Zusammenfassung

Fresenius Kabi USA is seeking a Chemistry and Stability Supervisor to oversee daily activities in the Chemistry and Stability Departments. You will ensure testing, release, and reporting meet quality, regulatory and customer requirements, while guiding Stability Coordination staff and interfacing with Operations, QA, and Regulatory Affairs.

The role includes supervising staff, reviewing stability protocols, and supporting investigations and CAPAs to uphold product integrity.

Qualifikationen

• Bachelor's degree in Chemistry or related science required.
• Five to ten years of progressive pharmaceutical lab experience.
• Strong verbal and written communication skills.
• Knowledge of regulatory requirements and cGMP.

Aufgaben

• Coordinate training and development of department personnel.
• Monitor daily activities to ensure timely release of materials and data.
• Provide technical guidance on processes, products and methods.
• Lead investigations for non-conforming materials and CAPAs.
• Support regulatory submissions and stability program maintenance.
• Manage department budget and prepare management reviews.

Kenntnisse

Leadership

Communication

Analytical thinking

Ausbildung

Bachelor's degree in Chemistry

Jobbeschreibung

Fresenius Kabi USA is seeking a Chemistry and Stability Supervisor to oversee daily activities in the Chemistry and Stability Departments. You will ensure testing, release, and reporting meet quality, regulatory and customer requirements, while guiding Stability Coordination staff and interfacing with Operations, QA, and Regulatory Affairs.

The role includes supervising staff, reviewing stability protocols, and supporting investigations and CAPAs to uphold product integrity.