GMP QA Specialist: Batch Release & Compliance

jj; Leiden; On-site; EUR 38,000 - 61,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Bereavement leave

Well-being reimbursement

Job summary

Johnson & Johnson Leiden is seeking an Associate Specialist QA to ensure GMP compliance across the product lifecycle in a manufacturing environment. You will collaborate with Operations, Quality Control, Engineering, and Development to uphold quality systems and regulatory standards.

The role focuses on batch release, documentation management, and continuous improvement while fostering a strong quality culture across the organization. English proficiency is essential; Dutch is a plus.

Qualifications

• Bachelor’s degree or higher in Biochemistry, Biology, Pharmacy, Life Sciences, or a related scientific discipline.
• Minimum of 2 years of experience in a GMP-regulated environment within Quality Assurance or related function.
• Strong understanding of GMP regulations, quality systems, batch release, and change control.

Responsibilities

• Perform electronic batch record reviews and support batch disposition activities per GMP requirements.
• Review and release raw materials while maintaining accurate material master data in quality systems.
• Assess, approve, and verify change controls to ensure compliance and effective implementation of process changes.
• Review and approve GMP documents, including master batch records, validation reviews, and shipment-related documentation.
• Prepare release packages for Qualified Persons (QP) and support product release processes.
• Participate in local and global quality projects and support process optimization initiatives.

Skills

English

Quality assurance

Regulatory compliance

Documentation

Dutch language (nice to have)

Education

Bachelor’s degree in Life Sciences

Job description

Johnson & Johnson Leiden is seeking an Associate Specialist QA to ensure GMP compliance across the product lifecycle in a manufacturing environment. You will collaborate with Operations, Quality Control, Engineering, and Development to uphold quality systems and regulatory standards.

The role focuses on batch release, documentation management, and continuous improvement while fostering a strong quality culture across the organization. English proficiency is essential; Dutch is a plus.