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

Lonza Group; Oberwallis; Remote; CHF 110,000 - 140,000; Full time

Benefits offered by this job

Agile culture and dynamic working

Inclusive and ethical workplace

Competitive compensation programs

Benefits vary by role/location

Job summary

Lonza Visp is seeking a Senior QA Specialist to provide QA oversight for buffer manufacturing, ensuring cGMP compliance and batch release readiness. The role sits within a single-use technology facility, collaborating with Manufacturing, MSAT, QC and cross-functional teams to maintain inspection readiness and data integrity.

You will review batch records and manufacturing documentation, lead deviations, CAPAs, and change controls, and support trainings and regulatory interactions.

Qualifications

• Academic degree in Chemistry/Biotechnology/Life Sciences or related field.
• Significant experience in a GMP-regulated pharmaceutical or biotechnology environment.
• Strong knowledge of GMP quality systems 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 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

Quality systems knowledge

GMP requirements

SOPs review

Batch records review

Documentation management

Regulatory inspections experience

English fluency

Education

Chemistry/Biotech/Life Sciences degree

Tools

TrackWise

SAP

DMS

LIMS

Job description

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.