Quality Assurance Specialist

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

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About Innovative Medicine  

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. 

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. 

Learn more at https://www.jnj.com/innovative-medicine 

We are searching for the best talent for a Quality Assurance Specialist position to be located in Sassenheim, Netherlands.

The contract will initially commence as a 12‑month fixed‑term agreement, with the possibility of extension subject to satisfactory performance and business needs.

QA-AT supports the clinical and commercial manufacturing of Lentivirus, an important component for Johnson and Johnson’s CAR-T therapy.

The QA Specialist 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 Specialist QA works in close collaboration with other local or global departments (Operations, Warehouse, QC, GET, MSAT and other site Quality teams).

Purpose: The QA specialist will focus primarily on AQL execution. AQL (Acceptable Quality Level) is applied as a risk mitigation to the visual inspection process by random re-inspection of a statistically relevant sample size. Thereby concluding on the quality of the original inspection process and overall batch acceptability. Additionally, the QA specialist will perform quality oversight activities throughout the different manufacturing stages , ensuring that the tasks being performed are in compliance with established best practices, guidelines and procedures.

As a Quality Assurance Specialist, you will:

• Reviews and approves routine GMP documentation for all components of the Quality system.
• Reviews and approves validation protocols and reports, CSV documentation, change controls, validation assessments, URS and applicable lifecycle documentation.
• Reviews and approves release documentation for (raw) materials or Drug Substance , including QA review of electronic batch records and related documentation (e.g., QC test results, QC trending data, SAP tags and related change controls).
• Reviews and approves Maintenance notifications and work orders (NI-NS) and SAP-PM Master Data Changes (N2, N5 and N6), as well as the approval of Maintenance and Calibration related documents (as needed).
• Executes Quality Aseptic Processing Oversight activities, verifying that operations are executed as supposed to and supports various Quality on the floor initiatives.
• Track and monitor progress of changes to anticipate, flag and prevent any delays in change implementation.
• Performs the Quality review of Periodic Review reports.
• Quality overview of the validated state of the utilities, equipment and processes.
• 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.
• Escalates serious quality, compliance and /or GMP incidents to management.
• On a rotation basis is available for beeper duty on out office hours and if quality oversight is needed during manufacturing (e.g. QAPOP)

Experience and Skills

• Degree in science related subject and /or business-related area with a minimum of 1 year work experience in a GMP regulated environment (manufacturing, QA and/or QC) in a pharmaceutical company.
• Must be currently based in The Netherlands.
• Knowledge of current Quality Management principles, GMP and Quality Systems, Pharma regulations.
• Knowledge of aseptic processing techniques and sterile manufacturing requirements is desired.
• Strong written and verbal communication skills to effectively negotiate and interact with various stakeholders.
• Problem solving, analytical thinking and decision making capabilities.
• Demonstrated proficiency in English both in word and in writing. Dutch is a pre but not mandatory.

The role is expected to be able to support a 16/7 shift schedule according to manufacturing planning (e.g. including evening and weekend schedule).

Salary:

The anticipated base pay range for this position is 44,700.00 to 70,840.00

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.

At Johnson & Johnson, we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear, fair, and respectful of your time.

Here’s what you can expect:

• Application review: We’ll carefully review your CV to see how your skills and experience align with the role.
• Getting to know you: If there’s a good match, you’ll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.
• Staying informed: We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.
• Final steps: For successful candidates, you will need to complete country-specific checks before starting your new role. We will help guide you through these.

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