Onsite QA Specialist — GMP Compliance & Impact

Lonza; Geleen; On-site; Confidential; Full time

Job summary

Lonza in Geleen, Netherlands is recruiting a QA Specialist / Officer II to support GMP operations and drive quality improvements on the floor. You will review batch records, approve deviations and CAPAs, and ensure documentation integrity in a fast-paced manufacturing environment.

The role requires a life sciences degree and GMP experience, excellent attention to detail, and strong communication with cross-functional teams.

Qualifications

• Bachelor's or Master's degree in Biotechnology, Life Sciences, Chemistry or another relevant scientific discipline.
• Experience in GMP‑regulated manufacturing environment, ideally biotechnology or pharmaceutical manufacturing.
• Experience in Quality Assurance or 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.
• Business‑fluent English, both written and spoken.

Responsibilities

• 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.

Skills

Attention to detail

Communication skills

Cross-functional collaboration

English proficiency

Education

Bachelor's or Master's degree in Biotechnology, Life Sciences, Chemistry or another relevant scientific discipline

Job description

Lonza in Geleen, Netherlands is recruiting a QA Specialist / Officer II to support GMP operations and drive quality improvements on the floor. You will review batch records, approve deviations and CAPAs, and ensure documentation integrity in a fast-paced manufacturing environment.

The role requires a life sciences degree and GMP experience, excellent attention to detail, and strong communication with cross-functional teams.