Key Skills

Job Description

Non-Conformance Specialist (QC-Microbiology) Location: Leiden Working mode: Hybrid with a minimum of 3 days per week on-site (induction period fully on-site) Duration: 12 months Hours: Full-time (40 hours or minimum 32 hours) Imagine your next project directly contributing to product quality and patient safety at Johnson & Johnson Innovative Medicine in Leiden, where you will safeguard compliance, lead critical deviation investigations, and continuously improve pharmaceutical processes alongside a supportive 40-person department with structured onboarding. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Purpose As a Non-conformance Specialist, you directly contribute to product quality and patient safety by investigating and resolving quality deviations. You are a key figure in safeguarding compliance and continuously improving our processes. You 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. 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. 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. Strong background in leading deviation investigations and quality management systems. 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, including excellent communication skills for stakeholder networking across operations and manufacturing. 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 (starting ASAP). you are welcome here Johnson & Johnson Innovative Medicine 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”.

Core Responsibilities

Lead investigations into quality non-conformances and manage related records, corrective and preventive actions, root cause analyses, and product impact assessments. Maintain compliant documentation, support audits and inspections, escalate serious incidents, and collaborate across departments to improve quality processes.

Requirements

A bachelor's or master's degree in a scientific discipline is required, with a microbiology background considered an advantage. Candidates need 3–5 years of relevant pharmaceutical Quality Control, Quality Assurance, or related experience, strong investigation and quality-system knowledge, and excellent English communication skills; GMP experience and Dutch proficiency are advantages.