Quality Non-Conformance Specialist - CAPA & Root Cause

CLS Services; Leiden; On-site; EUR 40,000 - 55,000; Full time

Benefits offered by this job

Contract for at least one year

36 days leave per year

On-site work

Job summary

Johnson & Johnson Innovative Medicine in Leiden seeks a Non-Conformance Specialist to manage and document GMP non-conformances in the Separations QC department. You lead investigations, define CAPAs, and ensure regulatory compliance for drug substances and products.

You will work with QA, Manufacturing, Regulatory Affairs and other teams to resolve quality issues, with emphasis on root cause analysis and continuous improvement of QC workflows.

Qualifications

• Bachelor's or Master's in a scientific discipline.
• Advanced degree or certification such as Six Sigma or ISP is a plus.
• Minimum 3–5 years in Quality Control/Quality Assurance in pharma with NC focus.
• Hands-on experience with NCs, CAPAs and ACTs relating to lab issues is essential.
• Familiarity with HPLC and separation techniques is advantageous.

Responsibilities

• Manage and document non-conformances in GMP-compliant systems.
• Lead investigations using structured tools (Fishbone, 5 Whys, KT).
• Define, coordinate and implement CAPAs and effectiveness checks.
• Assess impact on product quality and disposition; support audits and inspections.
• Monitor trends in NCs and contribute to improvement of quality systems.
• Support training on non-conformance management for staff.

Skills

Non-Conformance Management

GMP Compliance

Root Cause Analysis

Quality Control

Separation techniques (HPLC)

Education

Bachelor's or Master's degree in Chemistry, Biology, Pharmaceutical Sciences or related

Advanced degree or certification such as Six Sigma or ISP

Tools

QMS

HPLC

cIEF

cSDS

Job description

Johnson & Johnson Innovative Medicine in Leiden seeks a Non-Conformance Specialist to manage and document GMP non-conformances in the Separations QC department. You lead investigations, define CAPAs, and ensure regulatory compliance for drug substances and products.

You will work with QA, Manufacturing, Regulatory Affairs and other teams to resolve quality issues, with emphasis on root cause analysis and continuous improvement of QC workflows.