GMP QC Lab Compliance Lead – RCA & CAPA

Lonza; Basel; Vor Ort; Vertraulich; Vollzeit

Zusammenfassung

Lonza Basel is seeking an experienced quality compliance specialist in analytical chemistry to drive compliance and operational excellence within our QC laboratories supporting biopharmaceutical manufacturing.

You will lead end-to-end deviation investigations, root-cause analysis (RCA) and CAPA plans, write and manage Quality Change Requests, and act as a bridge between QC analytical teams and central QA. This 12‑month, site‑based role offers 41 hours per week and a competitive hourly rate.

Qualifikationen

• Minimum 5 years of practical experience in analytical chemistry, bioanalytics or GMP laboratory environments.
• Experience authoring quality-relevant records, managing deviations, RCA and CAPA implementation.
• Strong GMP knowledge, analytical methods, data integrity and instrument qualification.
• Hands-on RCA in a laboratory setting.
• Bachelor's degree in Chemistry/Biochemistry/Pharmaceutical Sciences (MSc or PhD preferred).
• Professional fluency in English; basic German is an advantage.
• Excellent interpersonal and communication skills.

Aufgaben

• Drive compliance and operational excellence within QC analytical laboratories supporting biopharmaceutical manufacturing.
• Lead end-to-end deviation investigations, root-cause analysis (RCA) and CAPA plans.
• Write, review and manage Quality Change Requests and associated quality-relevant documentation to meet tight submission timelines.
• Act as a key compliance bridge between QC analytical teams and central Quality Assurance (QA) stakeholders.
• Partner directly with lab technicians, conducting interviews and gathering analytical data across physico-chemical and bioanalytical workflows.
• Support compliance activities related to sample management processes and analytical instrument qualification protocols.
• Foster continuous process improvement within the QC track systems and mentor lab staff on data integrity standards.

Kenntnisse

GMP knowledge

Data integrity

CAPA

Root-cause analysis

Analytical chemistry

Documentation

QC labs

English fluency

Ausbildung

BSc in Chemistry/Biochemistry/Pharmaceutical Sciences

Jobbeschreibung

Lonza Basel is seeking an experienced quality compliance specialist in analytical chemistry to drive compliance and operational excellence within our QC laboratories supporting biopharmaceutical manufacturing.

You will lead end-to-end deviation investigations, root-cause analysis (RCA) and CAPA plans, write and manage Quality Change Requests, and act as a bridge between QC analytical teams and central QA. This 12‑month, site‑based role offers 41 hours per week and a competitive hourly rate.