QA Specialist

QA Specialist

Location: Leiden, Netherlands (Hybrid, 3 days per week onsite)

Duration: 12 months

Hours: 39 hours

Imagine your next project acting as the linking pin in investigations into Non Conformances, driving the improvement of the overall quality status in a dynamic and varied environment.

We are looking for an enthusiastic, highly motivated, and driven colleague to take up this phenomenal new opportunity as a QA Associate. In this challenging role, you will help us to strengthen our QA team at Johnson and Johnson Innovative Medicine, willing to contribute to a high-quality organization for the site and J&J.

The Quality Assurance department ensures that quality systems are applied as per GMP standards within J&J Innovative Medicine and is responsible for handling non-conformances, bulk product and intermediate product release, and change control. The QA department plays an important role in providing advice on quality topics to all departments of the supply chain.

The QA associate will be responsible for the improvement of the overall quality status. The activities are very dynamic and varied. The candidate likes challenges, doesn’t avoid problems and enjoys working in various teams.

roles and responsibilities.

• Ensure that in a timely manner a clear and quality prospected advice is given to all cGMP and/or quality related issues encountered during (non)routine operations.

• Lead all aspects of site investigations and ensure that all CAPAs are implemented and effective within agreed timelines.

• Assist in the preparations for and during inspections (FDA, EMA etc.) to accomplish a successful audit.

• Perform level assessment, review and approval of (deviation related) change controls.

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

• Assess, review and approve study protocols and reports to assure that studies will be executed in a controlled and systematic manner conform cGMP and regulatory requirements e.g. but not limited to stability, validation.

• Act as member in Quality Risk Management and /or root cause investigation sessions.

how to succeed.

Minimum education and experience required for the position. We would love to hear from YOU, if you have the following essential requirements:

• BSc in bioscience, chemistry, pharmacy or related subject with 4-6 years of experience.

• Msc in bioscience, chemistry, pharmacy or related subject with 2-4 years of experience.

• Good communicative, collaboration and advisory skills in Engish.

• Up to date knowledge of GMP regulations.

• Preferably Quality Assurance experience in pharmaceutical or related industry.

• Experience with quality investigations, root cause problem solving and quality risk management, preferred.

• Familiarity with PE, LEAN tools, concepts and methodologies is preferable.

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”.