Quality Analyst

Non-conformance Specialist (QC Microbiology)

Location: Leiden (Hybrid working - 3 days on site, 2 remote)

Duration: 12 month contract

Hours: Full-time (40 hours) or part-time (minimum 32 hours) negotiable

Please note this role does not accept freelancers

Imagine your next project where you will have direct involvement in quality-critical processes within a regulated manufacturing environment, with visibility across multiple departments. You will have the opportunity to build expertise in investigation, compliance and continuous improvement, while contributing to inspection readiness and product quality.

We are looking for the best talent for Non-conformance Specialists (QC Microbiology). As a Non-conformance Specialist, they directly contribute to product quality and patient safety by investigating and resolving quality deviations. They are a key figure in safeguarding compliance and continuously improving our processes. They are responsible for independently managing quality records – including Non-Conformances (NCs), Corrective and Preventive Actions (CAPAs), Assigned Corrective Tasks (ACTs) and Laboratory Investigation Records (LIRs) – within the Quality Control Microbiology department of Johnson & Johnson Innovative Medicine in Leiden. The initial focus of this role is on the QC Microbiology department. However, the organisation reserves the right to deploy the Non-conformance Specialist, based on operational needs and capacity requirements, to support quality records within other departments, including but not limited to other QC departments and manufacturing departments. 

roles and responsibilities

• Non-conformance investigation: Lead and conduct investigations into non-conformances related to, among others, testing of raw materials, in-process materials, Drug Substance, Drug Product and ancillary processes, without limitation to these areas.

• Associated quality records: Define, coordinate and/or implement corrections, corrective and preventive actions (CAPAs), effectiveness checks and other records arising from non-conformances.

• Root cause analysis: Perform root cause analyses using structured tools (including Fishbone, 5 Whys, KT analysis, operator interviews) and ensure that appropriate corrective and preventive actions are defined and implemented.

• Product impact analysis: Assess non-conformances for possible impact on product quality and/or compliance status, and advise on product disposition.

• Documentation, reporting and trending: Accurately document investigation findings and ensure timely and correct recording of all related activities. Maintain clear, organised records for audits and inspections. Contribute to trending and reporting of quality data for management reviews and continuous improvement.

• Regulatory compliance and inspections: Ensure all non-conformances are handled in accordance with local and global procedures and relevant pharmaceutical guidelines (including FDA, EMA, ICH, cGMP) and internal quality standards. Act as Subject Matter Expert (SME) and participate in (the preparation of) internal audits and external inspections.

• Escalation: Escalate serious quality, compliance and/or GMP incidents to departmental management and participate in site or global escalation meetings depending on the scope of the incident.

• Cross-functional collaboration: Work closely with relevant departments and stakeholders to resolve quality issues and ensure compliance with internal and external standards.

• Continuous improvement: Contribute to ongoing quality improvement initiatives and provide input for optimisation of quality systems, processes and workflows, with the aim of enhancing process quality and inspection readiness.

• Other departments: Support quality records within departments other than QC Microbiology when operational needs require.

• Secondary responsibilities

• Documentation and procedures: Update, review and approve SOPs, Technical Master Documents (TMDs), work instructions and other GMP documentation in the context of continuous improvement or as a result of corrective and/or preventive actions.

• Training and support: Contribute to developing and delivering training related to non-conformance management and investigation processes for internal staff.

• Other: Other tasks and responsibilities related to cGMP and compliance may apply, including the handling of Change Controls when required by the organisation, as indicated by the supervisor.

how to succeed

• Bachelor’s or Master’s degree in a scientific discipline such as Chemistry, Biology, Pharmaceutical Sciences or a related field. A microbiology background is a strong advantage.

• Minimum of 3 years (MSc) to 5 years (BSc) of experience in Quality Control, Quality Assurance or a related field within the pharmaceutical industry, preferably with a focus on non-conformance management and investigation.

• Experience in a GMP environment is a plus.

Knowledge and skills

• Solid knowledge of relevant local and global procedures and basic understanding of GMP regulations and FDA and EMA guidelines.

• Experience with COMET (or comparable quality management system) is a plus.

• Experience with Labvantage eLIMS is a plus.

• Excellent written and verbal communication skills in English.

• Proficiency in Dutch is a plus.

• Personal attributes

• Solid analytical and problem-solving skills with experience in root cause analysis.

• Detail-oriented with the ability to manage multiple tasks while maintaining high standards of quality.

• Effective organisational skills with the ability to prioritise and meet deadlines.

• Takes initiative, identifies opportunities for improvement and is able to work both independently and in teams.

• A continuous improvement mindset, with a commitment to product quality and regulatory compliance.

benefits

This role offers a very competitive hourly rate. This contract will run for 12 months.

you are welcome here

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson Innovative Medicine

Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow. Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina. We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.

application process

We are looking to process the first round of applications within the next 2 working days. We do not accept applications via email or LinkedIn InMail - you must apply direct to this advert.

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”. Johnson & Johnson is committed to an inclusive work environment where everyone belongs. We encourage candidates of all backgrounds, experience levels and perspectives to apply. If you do not recognise yourself in every aspect of the profile but are enthusiastic about this role, we warmly invite you to respond.