Johnson & Johnson
Associate Scientist
Associate Scientist Compliance Management
Location: Leiden
Working mode: Fully on-site (opportunity to work occasionally from home once established in the role)
Duration: 6 months
Hours: 40 per week (usual business hours)
Department:
The Strategic Operations (SO) group is part of the Analytical Development (AD) Department of the Advanced Therapeutics AD sector of J&J Innovative medicine.
The SO group focuses on supporting production and laboratory activities with:
Assuring compliance to GMP standard.
Execution of all internal release, stability and PAS testing.
Maintaining controlled state of the production clean room and production utilities by environmental and utility monitoring programs and performing safety testing on our products.
Inspection, release and change management of incoming production raw materials, laboratory chemicals and Lab supplies.
Sample and Material receipt, handling, storage and forwarding.
Cell Culture services where cells are maintained used for assays and production cell line quality is supported.
Coordination of Release and Stability testing and Outsource testing.
Managing the data systems, equipment and automation solutions in the AD
We are looking for someone motivated who enjoys working in a multidisciplinary environment with different stakeholders.
Within the Compliance Management team the following tasks are included but are not limited to:
Review document revisions
Lead document revisions
Manage Change Controls
Process non-conformance/CAPA records
Having close contact with stakeholders
Manage training curricula of AD employees
Perform self inspections within the department
Design and implement improvements regarding quality and compliance
how to succeed
MLO-4
Experience with cGMP
Affinity and experience with (laboratory) systems such as COMET, TruVault, and SUMMIT.
2-5 years of work experience with compliance management related activities.
Developed interpersonal skills and able to build strong relationships.
Experience working in a Quality driven environment.
Good communication in English (written and verbally).
benefits
This role offers a very competitive hourly rate. This contract will run for 6 months.
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.
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”.