GMP Officer (QC)

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

Are you an experienced quality compliance specialist in analytical chemistry looking to make a direct impact on life‑saving biopharmaceutical products? Join our Quality Control team in Basel to drive critical laboratory compliance, deviation investigations, and root‑cause analyses.

Fully site‑based roles

This is a fully site‑based role. Working together in person supports close, real‑time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.

Start date: As soon as possible

Contract: Duration: 12 months

Hours: 41 hours per week

What you will get:

• An agile career and dynamic working culture.
• An inclusive and ethical workplace.
• Competitive hourly rate.

Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge.

What you will do:

• Drive compliance and operational excellence within our Quality Control analytical laboratories supporting biopharmaceutical manufacturing.
• Lead end‑to‑end deviation investigations, root‑cause analysis (RCA) and author comprehensive Corrective and Preventive Action (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 Quality Control (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.

What we are looking for:

• Minimum 5 years of practical experience within analytical chemistry, bioanalytics or a GMP laboratory environment.
• Proven expertise in authoring quality‑relevant records, managing deviations, OOX investigations and CAPA implementation.
• Strong practical knowledge of GMP principles, analytical methods, data integrity, instrument qualification and sample management.
• Demonstrated hands‑on experience performing structured root‑cause analysis techniques in a laboratory setting.
• Educational background with a Bachelor's degree (BSc required; MSc or PhD preferred) in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related discipline.
• Professional business fluency in English (written and spoken) is required; basic German language skills are an advantage.
• Excellent interpersonal and communication skills to effectively collaborate with lab personnel and align with QA decision‑makers.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment.

As Lonza’s talent acquisition partner, please note, Randstad is responsible for the engagement and contracting of this contingent role.