Non-Conformance Specialist

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

Vacancy number: A-2-2600067

Johnson & Johnson Innovative Medicine - Leiden (Nederland)

For our client, Johnson & Johnson Innovative Medicine, we are looking for a Non-Conformance Specialist.

Keywords

• Non-Conformance Management
• GMP Compliance
• Root Cause Analysis
• Quality Control
• Separation techniques (HPLC)

Profile

As Non-Conformance (NC) Specialist within the Separations QC department at Janssen Biologics, you are responsible for performing, documenting, and managing non-conformances in accordance with GMP and regulatory requirements. You lead investigations related to testing of raw materials, in-process materials, drug substances and drug products, and conduct root cause analyses using structured tools such as Fishbone, 5 Whys and KT analysis. Based on your findings, you define, coordinate and implement corrections, corrective and preventive actions (CAPAs) and effectiveness checks.

You assess the potential product quality and compliance impact of non-conformances and provide recommendations on product disposition. You maintain accurate and well-organised records for internal and external audits and inspections, and act as SME during these activities. You work closely with cross-functional teams including Quality Assurance, Manufacturing, PQM, DPDS and Regulatory Affairs to resolve quality issues and ensure compliance with FDA, EMA, ICH and cGMP guidelines.

• Monitor and analyse trends in non-conformances and contribute to periodic trend reports (e.g. OOS/OOT).
• Contribute to training programmes related to non-conformance management for internal staff.
• Support continuous improvement initiatives and help optimise quality systems and workflows.

Who we're looking for

You hold a Bachelor's or Master's degree in Chemistry, Biology, Pharmaceutical Sciences or a related scientific discipline. An advanced degree or certification such as Six Sigma or ISP is a plus. You bring a minimum of 3 years (MSc) to 5 years (BSc) of experience in Quality Control, Quality Assurance or a related field within the pharmaceutical industry, with a demonstrable focus on non-conformance management and investigation. Prior hands-on experience with NCs, CAPAs and ACTs relating to laboratory issues is essential; familiarity with HPLC and/or separation techniques is a strong advantage.

• Solid understanding of GMP regulations, FDA and EMA guidelines and quality control best practices.
• Strong analytical and problem-solving skills, including experience with root cause analysis methodologies.
• Proficient in quality management systems (QMS) and investigation tools; strong written and verbal communication skills in English.
• Proactive, detail-oriented and able to prioritise effectively while maintaining high quality standards.

Department

The role is situated within the Separations QC department, which works with test methods including cIEF, cSDS, HPLC, particle analysis and glidability. The NC Specialist reports to a (Senior) Supervisor within this department.

Company profile

Janssen Biologics develops, acquires and markets innovative biopharmaceutical therapies, with a focus on three major disease areas: cardiovascular conditions, immunological disorders and oncology. The organisation is committed to advancing both new and existing products through targeted research, strategic partnerships and the development of highly qualified people. Quality and compliance are central to everything they do.

Additional vacancy information

Reference:A-2-2600067 Contract:Temporary contract Education:WO/MSc. Arbeidsvoorwaarden :

Contract for at least one year.

Salary: 40000-55000

Days of leave: 36