Senior QA Specialist, QA Operations (Buffer Manufacturing) 80-100% (f/m/d)

Lonza; Oberwallis; Remote; CHF 120,000 - 150,000; Full time

Benefits offered by this job

Agile culture

Inclusive workplace

Performance rewards

Benefits by role

Job summary

Lonza in Visp, Switzerland, is seeking a Senior QA Specialist to provide QA oversight for buffer manufacturing operations, ensuring cGMP compliance and quality standards. You will review batch records, SOPs, and quality records, and lead deviations, CAPAs, change controls, and risk assessments.

You will collaborate with Manufacturing, MSAT, QC, and other teams to resolve issues and drive continuous improvement, supporting timely batch releases and data integrity.

Qualifications

• 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.

Responsibilities

• 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.

Skills

QA oversight

GMP experience

Deviation handling

CAPA process

Change controls

Batch record review

Documentation control

TrackWise

SAP

DMS

LIMS

Quality systems

English fluency

German a plus

Education

Degree in Chemistry/Biotechnology/Life Sciences

Tools

TrackWise

SAP

DMS

LIMS

Job description

Senior QA Specialist, QA Operations (Buffer Manufacturing) 80-100% (f/m/d)

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
• 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.

• Take ownership, step forward, and enjoy meaningful responsibility
• Love solving problems and thrive in a complex, fast-moving environment
• Are curious, always looking to learn and improve
• Work collaboratively, contributing to something bigger than yourself
• Are motivated to make a difference through work that impacts customers and their patients

Why Lonza:

We are a place of unique opportunity, where your ideas, expertise and ambition can make a real difference. Here, will have the freedom to grow, the support to succeed and the chance to contribute to work that matters.

We are the makers of the medicines of tomorrow.