QC Microbiology Senior Specialist – GMP Lead

Incyte; Yverdon-les-Bains; Vor Ort; CHF 120.000 - 150.000; Vollzeit

Zusammenfassung

Incyte seeks a QC Microbiology Senior Specialist to coordinate and oversee microbiology activities across DS/DP/IPC/EM. You will act as SME for testing methods, lead deviations and CAPAs, and drive continuous improvement. Collaboration with QA, Manufacturing, Validation, and external labs is essential.

You will mentor technicians, support regulatory inspections, and maintain robust data integrity and GMP documentation. Fluency in English and knowledge of GMP/QC systems are required.

Qualifikationen

• Bachelor's degree in Microbiology, Biotechnology, Life Sciences, or related field with 5+ years in QC Microbiology.
• Hands-on experience with Bioburden, Endotoxin (LAL), Sterility Testing, Environmental/Utilities Monitoring.
• Experience with method verification, validation, transfer and lifecycle management.
• Knowledge of GMP, pharmacopoeias (USP/EP/JP), and data integrity.

Aufgaben

• Coordinate and oversee QC Microbiology activities supporting release of DS/DP/EM/IPC.
• Review and trend microbiological data, ensure GMP compliance and lead investigations.
• Serve as SME for microbiological testing methods and validation activities.
• Lead QA communication with cross-functional teams and drive CAPAs and change controls.
• Contribute to inspections, audits, and continuous improvement initiatives.

Kenntnisse

Autonomy

Ownership

Organizational skills

Planning

Communication

Stakeholder management

Team player

Continuous improvement

Coaching

English (Advanced)

French (Fluent)

Ausbildung

Bachelor's degree in Microbiology/ Biotechnology/ Life Sciences

Tools

LIMS

Electronic quality systems

Microsoft Office

Jobbeschreibung

Incyte seeks a QC Microbiology Senior Specialist to coordinate and oversee microbiology activities across DS/DP/IPC/EM. You will act as SME for testing methods, lead deviations and CAPAs, and drive continuous improvement. Collaboration with QA, Manufacturing, Validation, and external labs is essential.

You will mentor technicians, support regulatory inspections, and maintain robust data integrity and GMP documentation. Fluency in English and knowledge of GMP/QC systems are required.