Job Description - QA Lab Associate IPL CAR-T (2406227231W)
Description
CAR-T (chimeric antigen receptor T-cell therapy) is a new way to eliminate cancer cells, which work by harnessing the power of a patient’s own immune system. The patients’ own T cells are harvested and engineered to kill the cancer cells expressing a specific antigen.
To bring this life-saving therapy to the patients, Johnson & Johnson Innovative Medicine is looking for new talents to support the QA Lab organization! So don't hesitate, the patients are waiting!
The QA Lab Associate CAR-T is responsible for providing quality oversight for the in-process Lab of the CAR-T cellular therapy products in accordance with internal policies, standards, procedures, and Global cGMP’s.
Key Responsibilities:
* Provide compliance oversight for the IPL laboratories, ensuring accurate and timely review of laboratory investigations, performing analysis on quality indicating data and identifying any trends noted for QC data.
* Support drafting and approving of standard operating procedures.
* Perform spot-checks in the IPL Lab to ensure compliance with written regulations, policies, procedures, and global procedures.
* Ensure non-conformances are investigated thoroughly and approved in a timely manner and appropriate corrective and preventive action plans are implemented.
* Strive to reduce non-conformances in supported areas by proactively driving compliance.
* Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
* Critically support investigations and reports, interpret results, and generate technical conclusions consistent with quality risk management principles.
* Recognize patterns and trends in reported data and communicate to management.
* Provide guidance in the interpretation of quality issues and participate in the development of technical or scientific initiatives and activities.
* Routinely recognize and resolve quality issues. Seek management guidance on complex issues. Develop procedures.
* Be able to interpret complex results and situations with a degree of independence and articulate recommendations for solutions. Identify risk and develop contingency plans.
* Provide compliance oversight for Lab expansion projects including analytical instrument qualification.
Qualifications
Education:
* A minimum of a Master’s Degree in Engineering, Science or equivalent technical discipline is required.
Experience and Skills:
Required:
* A minimum of 2 years of experience in Quality Assurance.
* Knowledge of cGMP regulations and FDA/EU guidance is required.
Preferred:
* Experience in biotechnology methods like flow cytometry, cell counting and viability is preferred.
At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through innovative programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.
Primary Location
Europe/Middle East/Africa-Belgium-East Flanders-Ghent
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