Quality Assurance Specialist

QA Specialist 

We are considering Junior or Senior profiles for this role / We can not consider any freelance LTD company contractors for this role

Location: Leiden, Netherlands - Hybrid working - 3 days a week on site

Duration: 12 months

Hours: Full time

Pay rate range: 

Overview: We are seeking an enthusiastic and highly motivated colleague to enhance our Quality Assurance Operational Commercial Products (QA-OCP) team at Johnson & Johnson Innovative Medicine Biologics Leiden. This role is essential for fostering a high-quality organization on the site and within J&J.

Department: The Quality Assurance department plays a critical role in ensuring that quality systems comply with GMP (Good Manufacturing Practice) standards within J&J Innovative Medicine. The team is responsible for managing non-conformances, bulk product and intermediate product releases, and change control, while providing quality advice to all departments within the supply chain.

roles and responsibilities

• Provide timely and high-quality advice on cGMP (current Good Manufacturing Practice) and quality-related issues encountered during (non)routine operations.

• Lead all aspects of site investigations,  ensuring that all Corrective and Preventive Actions (CAPAs) are implemented effectively and within agreed timelines.

• Assist in the preparation for inspections (FDA, EMA, etc.) to ensure successful audit outcomes.

• Conduct assessments, reviews, and approvals of change controls related to  commercial production and quality control testing.

• Partner with site colleagues to ensure that all changes and projects are conducted in compliance with cGMP and company quality requirements.

• Assess, review, and approve study and validation protocols and reports to ensure that studies are conducted in a controlled and systematic manner in accordance with cGMP and regulatory requirements.

• Actively participate as a member in Quality Risk Management and root cause investigation sessions.

how to succeed

• A Bachelor’s degree in bioscience, chemistry, pharmacy, or a related field, with 4-6 years of relevant experience; OR a Master’s degree in bioscience, chemistry, pharmacy, or a related field, with 2-4 years of relevant experience.

• Strong communication, collaboration, and advisory skills in both Dutch and English (verbal and written).

• Up-to-date knowledge of GMP regulations.

• Preferably, experience in Quality Assurance within the pharmaceutical industry or a related field.

• Demonstrated experience with quality investigations, root cause problem-solving, and quality risk management.

• Familiarity with PE (process excellence), LEAN tools, concepts, and methodologies is preferred.

• Eligibility for the experienced specialist QA role is dependent on the level of relevant experience, which will be assessed during the job application process.

Key Attributes: We are looking for candidates who thrive on challenges, are solution-oriented, and appreciate the value of teamwork in a dynamic work environment. If you possess the qualifications and passion for quality assurance, we encourage you to apply!

benefits

This role offers a very competitive hourly rate. This contract will run for 12 months and has a strong chance of extension. 

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.

The pay rate for this role will depend on how you are paid. 

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”.