QA Specialist

Lonza Group Ltd.; Geleen; On-site; Confidential; Full time

Benefits offered by this job

Competitive pay

Benefits package

Growth opportunities

Job summary

Lonza Group Ltd. in Geleen, Netherlands, is seeking a QA Specialist to ensure GMP-compliant manufacturing and review of quality documentation. You will work closely with production and cross-functional teams to drive continuous improvement and maintain high quality standards on site.

The role emphasizes reviewing batch records, approving deviations and change controls, and supporting QA on the floor with robust quality oversight and metrics reporting. English proficiency required.

Qualifications

• Bachelor's or Master's degree in Biotechnology, Life Sciences, Chemistry or a related scientific discipline.
• Experience in GMP-regulated manufacturing, preferably biotech or pharmaceutical.
• Experience in QA or related quality function with GMP knowledge.
• Excellent attention to detail for reviewing technical documentation.
• Strong communication and collaboration across cross-functional teams.
• Ability to prioritize, solve problems, and escalate appropriately.
• Business-fluent English, written and spoken.

Responsibilities

• Partner with manufacturing and internal stakeholders as the QA SME, guiding GMP and quality-related activities.
• Review batch records and prepare documentation for batch disposition within timelines.
• Review and approve quality events including deviations, investigations, CAPAs and change controls.
• Review and approve quality documentation including SOPs, master batch records, protocols and reports.
• Support QA on the Floor activities with quality oversight during manufacturing, warehouse and QC.
• Contribute to quality metrics, KPI reporting and cross-functional quality meetings.
• Ensure batch documentation is completed, archived and product labels are issued or verified.

Skills

Quality Assurance

GMP compliance

Documentation review

CAPA investigations

Change control

SOPs

Education

Bachelor's or Master's in Life Sciences

Tools

Document management system

Job description

QA Specialist Geleen, Netherlands The actual location of this job is in Geleen, Netherlands. Join our Quality Assurance team and play a key role in ensuring that life-changing medicines are manufactured to the highest quality and compliance standards. As a QA Specialist / Officer II, you will work closely with manufacturing and cross-functional teams to support GMP operations, review quality documentation, and help drive continuous improvement across our production processes. 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 with opportunities for growth and development within a global life sciences company.

An inclusive, collaborative and ethical workplace where your ideas are valued.

Competitive compensation programs that recognize high performance.

A comprehensive benefits package tailored to your role and location.

Opportunities to work with cutting-edge biotechnology manufacturing technologies.

The full list of our global benefits can be found here: https://www.lonza.com/careers/benefits

The full-time annual base pay for this position in the Netherlands is expected to range between EUR 41,250 and EUR 57,750. Initial salary placement within this range will be determined based on role-related factors such as experience, qualifications, and expected contribution.

What you will do

• Partner with manufacturing and internal stakeholders as the Quality Assurance subject matter expert, providing guidance on GMP and quality-related activities.
• Review batch records and prepare documentation for batch disposition, ensuring completion within agreed timelines.
• Review and approve quality events including deviations, investigations, CAPAs and change controls while ensuring compliance with GMP requirements.
• Review and approve quality documentation including SOPs, master batch records, protocols, reports, forms and related documentation within the document management system.
• Support QA on the Floor activities by providing quality oversight during manufacturing, warehouse and quality control operations.
• Contribute to quality metrics, KPI reporting and cross-functional quality meetings to support continuous improvement initiatives.
• Ensure batch documentation is completed, archived and product labels are issued or verified in accordance with established procedures.

What we are looking for

• Bachelor's or Master's degree in Biotechnology, Life Sciences, Chemistry or another relevant scientific discipline.
• Experience working in a GMP-regulated manufacturing environment, ideally within biotechnology or pharmaceutical manufacturing.
• Experience in Quality Assurance or a related quality function with knowledge of GMP regulations and compliance requirements.
• Strong attention to detail with the ability to review technical documentation accurately and identify compliance risks.
• Excellent communication and collaboration skills, with the ability to build effective relationships across cross-functional teams.
• Ability to prioritize multiple activities, solve problems effectively and escalation issues appropriately when required.
• Business-fluent English, both written and spoken.

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.