QC Operations Project Specialist

Lonza; Basel; Vor Ort; Vertraulich; Vollzeit

Benefits dieser Stelle

Agile culture

Inclusive workplace

Competitive hourly rate

Zusammenfassung

Lonza in Basel is seeking a Clinical QC Phys-Chem Analytics professional on a 12-month contract to lead stability programs and quality deliverables for therapeutic drug products. This site-based role emphasizes operational execution across customer projects and close, real-time collaboration in person.

Responsibilities include authoring GMP documentation, coordinating studies, and ensuring readiness for audits while developing subject-matter expertise to advance toward future project leadership

Qualifikationen

• cGMP QC/Analytical Development experience.
• Experience with HPLC and compendial testing.
• Experience writing GMP documents and CAPA.
• Degree or Apprenticeship in Chemistry/Pharmaceutical Sciences.
• Fluent English and ability to coordinate across stakeholders.

Aufgaben

• Manage stability programs and quality deliverables for drug products.
• Collaborate with QA, Sample Management, and global testing labs.
• Coordinate stability studies from initiation to completion, tracking timelines.
• Author and review cGMP documentation including specifications and stability summaries.
• Initiate and progress quality records, deviations, OOX investigations, CAPA resolution.
• Maintain audit and inspection readiness across project deliverables.

Kenntnisse

cGMP QC experience

Analytical Development

Cross-functional collaboration

Fluent English

Ausbildung

Degree or Apprenticeship in Chemistry/Pharmaceutical Sciences

Tools

LIMS

Empower

Veeva

Jobbeschreibung

Join our Clinical QC Phys-Chem Analytics team in Basel to lead stability programs and quality deliverables supporting innovative biopharmaceutical drug products on a 12-month contract. This is a fully site-based role focused on operational execution across critical customer projects.

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.

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 health and life-science outcomes by managing stability programs and quality compliance for therapeutic drug products.
• Partner with cross-functional project teams, QA, Sample Management, and global testing laboratories.
• Coordinate assigned stability studies from initiation through completion, tracking timelines and mitigating operational risks.
• Author, review, and maintain cGMP documentation including analytical specifications, protocols, and stability summaries.
• Initiate and progress quality records, supporting deviations, OOX investigations, root-cause analyses, and CAPA resolution.
• Maintain audit and inspection readiness across all assigned project deliverables and analytical documentation.
• Develop operational subject-matter expertise across Drug Product analytics to build pathways toward future project leadership.

What we are looking for:

• Practical experience in a cGMP QC or Analytical Development environment supporting small or large molecule modalities.
• Technical understanding of physical-chemical analytical techniques (e.g., HPLC, compendial testing) and laboratory data tools (LIMS, Empower, Veeva).
• Proven track record of authoring GMP documentation and participating in quality event resolution (CAPA, Change Control, OOX, Deviations).
• Degree or Apprenticeship in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific field.
• Fluent English communication skills with the ability to coordinate across diverse scientific and operational stakeholders.

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.