QA Expert Analytics 9 months fix-term contract 80-100% (f/m/d)
About this role
The actual location of this job is in Basel Stücki, Switzerland.
For our successful Drug Product Services (DPS) focused branch located in Basel and Stein, Switzerland, we have exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and join us by applying for the fix-term contract QA Expert Analytics DP position.
What you will get:
An agile career and a dynamic work culture
An inclusive and ethical workplace
Compensation programs that recognize high performance
What you will do:
Provide QA support to QC functions (clinical and commercial) for GMP compliance-related activities within analytical testing laboratories, including physicochemical and bioassay testing.
Ensure implementation and adherence to Corporate GMP Quality Manuals and applicable quality standards across Drug Product testing sites.
Review and approve documentation related to:
Analytical method validation
Specifications
Release testing
Stability studies
Perform review and approval activities in electronic systems such as LIMS, iLab, DMS, and other GMP-relevant platforms.
Review and approve Change Controls, Deviations, OOS investigations, and CAPAs related to products, processes, and analytical activities.
Author, review, and approve GMP documents, including SOPs, procedures, gap assessments, and compliance-related tools.
Support analytical release activities and technical release of drug product batches.
Participate in and support customer audits, and health authority inspections.
Promote and enforce compliance with internal policies and external regulations, including GMP requirements, quality standards, and HSE regulations.
Collaborate with cross-functional stakeholders to drive continuous improvement and maintain a strong quality culture.
What we are looking for:
University degree in Pharmacy, Chemistry, Biotechnology, Life Sciences, or a related scientific discipline
Several years of experience within a GMP-regulated pharmaceutical or biotechnology environment. Proven experience in Quality Assurance supporting Quality Control laboratories and analytical testing activities
Strong knowledge of GMP regulations, quality systems, and analytical laboratory operations. Familiarity with electronic quality and laboratory systems such as LIMS, DMS, Trackwise or equivalent
Experience managing and reviewing Deviations, OOS investigations, CAPAs, and Change Controls
Good communication and stakeholder management skills within a matrix environment
Excellent knowledge of written and spoken English
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 for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.
Ready to shape the future of life sciences? Apply now.
Company at a glance
Lonza is a pioneer and world leader in the CDMO industry, setting the pace with cutting-edge science, smart technology, and lean manufacturing. United by a common purpose, we turn our customers’ breakthrough innovations into viable therapies and manufacture the medicines of tomorrow.
Founded in Switzerland in 1897, our company is the first and original CDMO, and today we are more dynamic, agile and forward-focused than ever before. As one of the largest Western CDMOs, we bring together a global team of around 18,500 colleagues across five continents to deliver comprehensive, integrated solutions for our customers' complex needs.
For our customers and their patients, we bring quality, safety and reliability to bring life-enhancing and life-saving treatments to market at speed and at scale. For our colleagues, we strive to create a sense of belonging and inclusion where every person can thrive and bring their best.
Top Benefits
- Agile career
- Dynamic work culture
- Inclusive workplace
- Ethical workplace
- Performance-based compensation programs
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