Senior QA Specialist - On-the-Plant Floor

Johnson & Johnson Co.; Amsterdam; On-site; EUR 65,000 - 105,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Job summary

Johnson & Johnson Leiden seeks a Senior Specialist, QA to join the Quality in the Plant team in Leiden, The Netherlands. You will provide proactive, real-time QA support within manufacturing operations, ensuring GMP compliance and strong quality culture.

You will oversee shop-floor quality, assist investigations and risk assessments, and collaborate with Operations, MSAT, Engineering, Quality Control and Training to strengthen quality across the site.

Qualifications

• Minimum 8 years in a GMP-regulated environment with a Bachelor’s, or 6 years with a Master’s, incl. 2+ years in QA and Manufacturing Operations
• Experience in QA, Manufacturing Operations, Quality Control or related pharmaceutical functions
• Experience leading investigations, quality risk assessments, and compliance decisions
• Strong knowledge of cGMP, ICH, FDA/EMA guidelines and risk-based QA decisions
• Experience with aseptic processing or biologics manufacturing preferred

Responsibilities

• Maintain active QA presence in manufacturing areas during assigned shifts
• Provide real-time quality guidance and oversight of GMP and aseptic operations
• Support non-conformances, investigations, CAPA, and risk management
• Participate in daily operations meetings and contribute to MES/SAP quality processes
• Coach operators and leaders on GMP requirements and quality expectations

Skills

Quality Assurance

GMP knowledge

Investigations

CAPA

Regulatory compliance

Education

Bachelor’s degree or higher in Biotechnology, Biology, Pharmacy, Chemistry, Life Sciences

Job description

Johnson & Johnson Leiden seeks a Senior Specialist, QA to join the Quality in the Plant team in Leiden, The Netherlands. You will provide proactive, real-time QA support within manufacturing operations, ensuring GMP compliance and strong quality culture.

You will oversee shop-floor quality, assist investigations and risk assessments, and collaborate with Operations, MSAT, Engineering, Quality Control and Training to strengthen quality across the site.