Quality Assurance Specialist

Quality Assurance Specialist (Experienced/Senior level)

Location: Sassenheim

Working mode: Hybrid, 3 days per week on-site and 2 WFH

Duration: 12 months

Hours: Full-time, 40 hours per week

We are seeking a highly motivated individual to join our QA Advanced Therapies team, located in Sassenheim, the Netherlands. QA-AT supports the clinical and commercial manufacturing of Lentivirus, an important component for Johnson and Johnson’s CAR-T therapy.

The Experienced Specialist QA acts as a quality expert and ensures quality oversight of our AT products and processes. Plays a crucial role in ensuring that our manufacturing operations meet the highest standards of quality and GMP compliance by supporting various base business activities needing quality assurance expertise. The Experienced Specialist QA works in close collaboration with other local or global departments (Operations, Warehouse, QC, GET, MSAT and other site Quality teams).

roles and responsibilities

• Assess and review the outcome of Quality Investigations, provide support as part of the investigation teams and monitor the quality of the Root Cause investigations. Assesses non-conformances for possible impact on product quality or compliance status and decide on product disposition.  

• Ensures that appropriate corrective and preventive actions (CAPAs) are identified and implemented in response to investigations, especially those with potential impacts on product quality and patient safety.

• Escalates serious quality, compliance and /or GMP incidents to management and support (Global) escalation of issues, which have potential impact on the delivery of products to patients.

• Participates in Hazard / Risk assessments to ensure compliance or quality is not jeopardized. 

• Coordinates, reviews, and provides GMP training (e.g., Non-conformances, Investigation techniques, Qualifications etc.) for site colleagues to ensure compliance to cGMP and company training requirements. 

• Provides review and approval of various document changes and change controls.

• Executes Quality Aseptic Processing Oversight activities, verifying that operations are executed as supposed to and supports various Quality on the floor initiatives.

• Promotes improvement initiatives to set up , standardize and lean out QA processes within the team.

• Provides Site support for local or global projects as an SME or QA core team member. 

• Engages in internal audits and inspections as an SME or in support functions.

• On a rotation basis is available for beeper duty on out office hours and if quality oversight is needed during manufacturing (e.g. QAPOP)

how to succeed

• Degree in science related subject and /or business-related area with more 4-6 years of experience in a GMP regulated environment (manufacturing, QA and/or QC) in a pharmaceutical company. Experience in a QA role for at least 2-4 years.

• Proven experience working with quality systems, ensuring compliance with industry standards, GMP principles and regulatory requirements. 

• Knowledge of aseptic processing techniques and sterile manufacturing requirements is highly desired.

• Experience in methods such as Process Excellence, Co Think or Kepner-Tregoe is recommended. 

• Strong written and verbal communication skills to effectively negotiate and interact with various stakeholders.

• Problem solving, analytical thinking and decision making capabilities.

• Highly organized, capable of managing multiple tasks in a team environment, and able to work effectively under minimal supervision while maintaining a positive attitude.

• Demonstrated proficiency in English both verbal and in writing. Dutch is a pre but not mandatory.

benefits

This role offers a very competitive hourly rate. This contract will run for 12 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”.