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Quality Assurance Associate II

Company: Johnson and Johnson
Location: Raritan
Posted on: March 17, 2023

Job Description:

Janssen Pharmaceuticals, Inc a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Assurance Associate II!At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at and follow us @JanssenGlobal. Janssen Biotech, Inc. is part of the Janssen Pharmaceutical Companies.Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and Legend Biotech USA Inc., have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR-T platform and investigational treatment.Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our cell therapy products? Apply today for this exciting opportunity to be part of the #CAR-T team!In this role, you will be providing quality oversight for daily activities related to the production of lentiviral vector in a controlled cGMP clean room environment. You will act as a liaison with other internal quality organizations to standardize policies, practices and procedures to increase quality and compliance and champion increased awareness of quality related concerns. Main responsibilities will include, but are not limited to: Partner with the GMP Operations teams to support technology transfer activities and manufacturing processes into the cGMP facility. Perform regularly scheduled oversight of manufacturing activities in a controlled clean room environment. Perform review and approval of completed batch records and production documentation in support of batch release activities including preparation of product release documentation. Review and approve controlled documents including standard operating procedures, master batch records, work instructions, validation protocols and reports, and technical studies. Ensure all non-conformances are fully investigated and effective corrective/preventive actions are implemented in a timely manner. Provide quality oversight of the maintenance program, including facility change requests, calibrations, corrective and preventative maintenance and pest control. Support change management processes including formal change controls by evaluating the proposed changes, assessing impact, and providing quality input on implementation plans. Participate in process improvement activities including assessing current processes, providing improvement input and working with partners to implement changes. Support site inspections and inspection readiness. Other duties may be assigned as necessary. Education: A minimum of a Bachelor's Degree is required, preferably in Engineering, Science or equivalent technical field Experience and Skills:Required: At least 2 years of industry experience in Quality Assurance related to manufacturing Ability to work in an aseptic processing environment (Grade B or ISO 7) Ability to be organized and capable of working in a team environment with a positive demeanor A high degree of accuracy and attention to detail, and excellent interpersonal, oral and written communication skills Ability to maintain written records of work performed in paper-based and computerized quality systems Preferred: Experience with quality support in clinical or commercial GMP manufacturing or support of QC laboratories Knowledge of cGMP regulations and FDA/EU guidance related to the manufacture of cell and gene therapy products as well as knowledge of Good Tissue Practices Other: First Shift Monday - Friday This position will be located primarily in Raritan, NJ and may require up to 10% domestic & international travel The anticipated base pay range for this position is $60,000 to $96,600 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 cutting-edge 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.For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit & 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.

Keywords: Johnson and Johnson, Trenton , Quality Assurance Associate II, Other , Raritan, New Jersey

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