Emplois audit associate (Hasselt)

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:

Non-Standard

Job Sub Function:

Workday Associate B

Job Category:

Non-Standard

All Job Posting Locations:

Beerse, Antwerp, Belgium

Job Description:

Johnson & Johnson is currently seeking a Quality Control – Micro analyst to join our CAR-T Hub located in Beerse.

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/.

CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a patient’s own immune system. They are created from the patients’ own T cells and are engineered to eliminate cancer cells expressing a specific antigen.

To support the CAR-T program in EMEA, Janssen has built two CAR-T manufacturing centers in the Ghent area (Belgium). The QC laboratories will be operated from the existing Janssen Beerse site.

The QC Micro analyst, CAR-T Europe is responsible for preparing and conducting testing of the different samples taken during the production process. You are responsible for ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations.

The candidate will be part of the weekend team, working on Saturday and Sunday. Working hours will be from 6am to 6pm. Possibly preceded by training period in week regime.

You will be responsible for:

• Perform analytical testing in compliance with all applicable specifications, procedures, GMP regulations.
• Maintain a safe work environment in compliance with all applicable environmental, health, and safety regulations.
• Perform peer review of laboratory data.
• Author and update SOPs, WIs and Protocols to support daily operations of the lab using the Document Management System.
• Support laboratory related investigation records and CAPAs.
• Assist in the execution of internal audits.
• Provide input to functional laboratory meetings.
• Provide input and take actions as a QC representative at cross-laboratory meetings.

Qualification and requirements:

• A minimum of a bachelor’s degree in a Scientific or related field is required
• A minimum of two (2) years of experience working in a cGMP compliant QC laboratory or equivalent is required.
• Understanding data generated from performing microbiological techniques is required.
• Detailed knowledge of Microbiological technologies, aseptic techniques used in the QC micro laboratory (CAR-T experience) is required.
• Experience in performing endotoxin testing, grow promotion testing, sterility testing & environmental monitoring testing is required.
• Basic knowledge of compendial (USP, EP, JP, etc.) requirements pertaining to their functional area of QC is preferred.
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint) is required.
• Excellent written and oral communication skill are required

What type of mark will YOU make?

By joining Johnson & Johnson you will find boundless opportunities to craft your path & amplify your impact inside & outside our walls. And with our commitment to be the world’s healthiest workforce you can strengthen your body as well and your mind. When you work at Johnson & Johnson you can touch over a Billion lives worldwide every day. And when you apply your talent to our collective purpose there’s no end to the lasting impact we can make together. And that changes everything.#RPOAMS