Non-conformance Specialist (qc Microbiology)

Johnson & Johnson Johnson & Johnson · Pharma · Leiden, South Holland, Netherlands

This role is for a Non-conformance Specialist in QC Microbiology at Johnson & Johnson. The primary focus is on investigating non-conformances in microbiology testing, managing corrective actions, and ensuring product quality and patient safety within a regulated pharmaceutical environment. It involves root-cause analysis, documentation, and collaboration with various teams.

What you'd actually do

  1. Lead thorough investigations of non-conformances in microbiology testing and related processes to protect product quality and safety.
  2. Define, coordinate, and implement corrections, CAPAs, ACTs, and effectiveness checks to close issues and prevent recurrence.
  3. Use structured root-cause methods (e.g., Fishbone, 5 Whys, KT) and interviews to identify causes and recommend robust corrective actions.
  4. Assess product impact and advise on disposition and regulatory/compliance implications.
  5. Maintain clear, timely documentation; contribute to trending and reporting for audits, inspections, and management review.

Skills

Required

  • Bachelor's or Master's degree in Chemistry, Biology, Pharmaceutical Sciences, or related field
  • 3 years’ (MSc) to 5 years’ (BSc) experience in QC, QA, or related roles in the pharmaceutical industry
  • non-conformance/investigation exposure
  • Solid understanding of GMP and relevant guidelines (FDA, EMA, ICH) and quality procedures
  • Practical experience with quality management and lab systems
  • Strong analytical, root-cause, and organizational skills
  • attention to detail
  • ability to manage multiple priorities
  • Clear written and verbal English

Nice to have

  • microbiology background
  • Dutch language
  • LabVantage eLIMS
  • collaborative communicator
  • works well independently and in cross-functional teams

What the JD emphasized

  • non-conformance
  • investigations
  • GMP
  • quality procedures