Senior QA Specialist, QA Operations (Buffer Manufacturing) 80-100% (f/m/d)
Lonza is hiring a Senior QA Specialist, QA Operations (Buffer Manufacturing) 80-100% (f/m/d). Level rates it ; you can apply on Lonza.
Level's read on this job
- Little AI ●○○○ is how Level rates this role: aI is not part of the work.
- Tools and skills the posting cites include Trackwise, SAP and Lims.
- Level classifies it as a senior role.
- Level lists 597 other open roles at Lonza.
- The role was posted in the last few days.
AI in this role
Provide QA oversight for buffer manufacturing operations ensuring cGMP compliance and driving continuous improvement.
Location: The actual location of this job is in Visp, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.
Join our team as a Senior QA Specialist (f/m/d) and play a key role in ensuring quality excellence within our single-use technology facility. In this position, you will provide Quality oversight for the production of high quality buffer solutions supporting a variety of biotech manufacturing processes and applications.
As a Quality representative, you will work closely with Manufacturing, MSAT, QC and other cross-functional teams to ensure compliance with cGMP requirements, promote a culture of quality and drive continuous improvement across operations.
What you will get:
- An agile career and dynamic working culture
- An inclusive and ethical workplace
- Compensation programs that recognize high performance
- A variety of benefits dependant on role and location
The full list of our global benefits can be also found on https://www.lonza.com/careers/benefits.
What you will do:
- Provide QA oversight for buffer manufacturing operations, ensuring compliance with cGMP requirements and quality standards.
- Review and approve batch records, manufacturing documentation, SOPs, and quality system records.
- Lead and support deviations, investigations, CAPAs, change controls, and risk assessments.
- Partner with Manufacturing, MSAT, QC, and other stakeholders to resolve quality issues and drive continuous improvement.
- Ensure timely batch release activities and support data integrity and documentation compliance.
- Perform QA on-the-floor activities, facility walkdowns, and operational quality monitoring.
- Support customer audits, regulatory inspections, and training initiatives while promoting a strong quality culture and inspection readiness.
What we are looking for:
- Academic degree in Chemistry/ Biotechnology/ Life Sciences or a related scientific discipline.
- Significant experience in a GMP-regulated pharmaceutical or biotechnology environment.
- Strong knowledge of quality systems and GMP requirements, including deviations, CAPAs, change controls, batch record review, and documentation management.
- Experience reviewing and approving GMP documentation, including SOPs, batch records, and quality records.
- Exposure to health authority interactions and regulatory inspections (e.g., Swissmedic, FDA) is desirable.
- Working knowledge of quality and manufacturing systems such as TrackWise, SAP, DMS, or LIMS is preferred.
- Self-motivated team player with a proactive, solution-oriented mindset and strong communication skills.
- Business fluent English is required; German knowledge is an advantage.
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.
How we rate this
Senior QA Specialist, QA Operations (Buffer Manufacturing) 80-100% (f/m/d) at Lonza rates 0 out of 100 for how much of the daily work is AI. That makes it Little AI (AI Level 1 of 4). The level is about AI in the job, not seniority.
Little AI. AI is not part of the work.
- ●●●● Builds AI80 to 100
- ●●●○ Works on AI60 to 79
- ●●○○ Uses AI40 to 59
- ●○○○ Little AI0 to 39
Levels come from how often the tools, models and workflows of the role are named in the posting itself. Read the description and count the AI tools, models and workflows it names.
Prepare for this job
Built from this posting and from similar jobs on Level.
Skills and AI tools this role asks for
Questions you could be asked
- Tell me about a project where cgmp was part of your work. What did you do?
- Tell me about a project where quality assurance was part of your work. What did you do?
- Tell me about a project where deviation investigation was part of your work. What did you do?
- Tell me about a project where capa was part of your work. What did you do?
- Tell me about a project where compliance was part of your work. What did you do?
Adapt your resume
- List these exact terms on your resume: Cgmp, Quality Assurance, Deviation Investigation, Capa, and Compliance. An applicant tracking system matches the wording, not the idea.
- Attach one line of real, concrete experience to at least one of them. A tool named with nothing behind it rarely survives a human read.
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