Senior Analyst, Technical Quality Assurance

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. Learn more at https://www.jnj.com

Job Function:
Quality

Job Sub Function:
Quality Assurance

Job Category:
Professional

All Job Posting Locations:
Leiden, South Holland, Netherlands

Job Description:

THE OPPORTUNITY

The Research & Development group of J&J Innovative Medicine discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases, cardiovascular and metabolism, and pulmonary hypertension.

The Drug Substance Development department in Leiden focuses on advanced therapies, a novel class of medical products that uses cell and gene therapies which have the potential to cure diseases where no treatment is currently available.

It's a very exciting field, as no established manufacturing platforms exist for these products.

That means that new processes need to be developed to ensure high-quality and efficient production of GMP material!

The Technical QA team is part of the Quality Assurance department at Janssen Vaccines & Prevention in Leiden which is transitioning to support advanced therapies.

The QA team is responsible for overseeing and supporting the quality systems, projects and facilities.

The work of QA to shape and deliver the right quality is key for the success of Janssen V&P.

You will ensure that the foundation is in place on which new products will be developed! The group is forward looking, working on improving processes, being customer focused and supports the need for speed.

We are recruiting a Sr.

QA Associate Technical QA to join our QA team.

We are seeking a highly motivated and independent individual who will be overseeing all aspects of the qualification and validation of equipment, utilities, and environmental conditions in our pilot plant and QC laboratories, with a focus on clean rooms and aseptic processing.

Key responsibilities:


* Perform QA oversight over equipment qualification, clean water and clean air systems and the associated clean rooms (including grade A areas) which are used for GMP biotechnological manufacturing.


* Support the management of quality incidents, corrective and preventive actions, and change controls.


* Represents Quality on cross-functional teams and participates in site initiatives and projects.


* Applies quality, scientific and engineering principles for problem solving and advise to the teams.

IT’S ALL ABOUT YOU

To be successful, you demonstrate the ability to communicate effe...