QC Microbiology Scientist II — Mentorship & Validation

Fresenius Kabi USA; Wilson (NC); Sur place; USD 40 000 - 56 000; Plein temps

Avantages offerts par ce poste

401(k) plan with company contributions

Paid vacation, holiday and personal 
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Health benefits: medical, dental and 


Vision coverage

Employee assistance program

Résumé du poste

Fresenius Kabi USA is seeking a Scientist II in Quality Control Microbiology to apply advanced microbiological test methods and mentor junior analysts. The role supports multiple groups within QC Microbiology, ensuring testing and data integrity across environmental monitoring, finished products testing, and validation activities.

The incumbent will train staff, contribute to SOPs, investigations, and CAPA activities, and maintain compliance with cGMPs and GLPs in a fast-paced manufacturing

Qualifications

• Experience with microbiology test methods and instrumentation.
• Ability to mentor and train junior analysts.
• Knowledge of cGMPs and GLPs in a QC microbiology setting.
• Experience with data review and SOP maintenance.

Responsabilités

• Understands department priorities and importance of planning ahead.
• Performs peer review of data for accuracy, completeness and conformance to specifications.
• Keeps supervisory personnel informed of events impacting operations and performance.
• Be able to articulate work related issues clearly to management and peers.
• Maintains knowledge of cGMPs and GLPs and current compendial methods.
• Teach or coordinate teaching of training modules and laboratory techniques to new analysts.
• Assists in authoring basic investigative studies (OOS, OOT, OOL) and other documents for QC Microbiology.
• Supports senior personnel in investigations, special testing and project work and derives root cause of incidents.

Connaissances

Microbiology methods

Mentoring

Data review

cGMPs/GLPs knowledge

Laboratory training

Outils

KabiTrack

LIMS

Description du poste

Fresenius Kabi USA is seeking a Scientist II in Quality Control Microbiology to apply advanced microbiological test methods and mentor junior analysts. The role supports multiple groups within QC Microbiology, ensuring testing and data integrity across environmental monitoring, finished products testing, and validation activities.

The incumbent will train staff, contribute to SOPs, investigations, and CAPA activities, and maintain compliance with cGMPs and GLPs in a fast-paced manufacturing