Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a Specialist III - Quality Assurance- CAR-T!
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 www.Janssen.com 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 pharmaceutical products? Apply today for this exciting opportunity!
The QA Batch Release Specialist III is responsible for providing quality oversight over the production of cell therapy to support clinical and commercial requirements in a sterile GMP environment.
- Review released documentation for all manufacturing activities carried out in accordance with Good Documentation Practices (GDP)
- Work in a team based, cross-functional environment to complete tasks required to meet business objectives
- Support Investigations team by providing quality and compliance input for continuous improvement and remediations; also, perform investigations for Product Quality Complaints
- Review, revise, or draft Standard Operating Procedures (SOPs) in relation to the cryopreservation process
- Aide to process improvement of batch records and turnaround times to ensure turnaround times and QA batch disposition deadlines
- Perform duties/tasks under minimal direction/supervision according to standard operating and manufacturing procedures and demonstrate ability to attain resources and information from established internal contacts
- Consistently perform tasks in adherence with safety policies, quality systems, and cGMP requirements, as well as according to state and federal regulatory requirements
- Strive to reduce non-conformances in supported areas by dedicatedly driving compliance
Ensure readiness of records for regulatory inspections and internal audits
- Minimum of a Bachelor’s degree in Engineering, Science, or equivalent technical field
Skills & Experience:
- Minimum 4 years of relevant work experience
- Quality Assurance experience within pharmaceutical or a related industry
- Knowledge and solid understanding of current Good Manufacturing Practices (cGMP) regulations and FDA/EU guidance
- Highly organized, with shown attention to detail and ability to follow the procedures with minimal direction
- Strong interpersonal skills, positive mentality, and capability of working in a collaborative team environment
- Proven writing skills and experience maintaining written records of work in the form of technical reports and/or protocols
- Proficient verbal communication skills, with the ability to optimally summarize and present results
- Experience in clinical quality, method development, or Research & Development
- Experience with aseptic processing in ISO 5 clean room
- Familiarity with Trackwise (quality event management), SAP Atlas, LIMS, or equivalent systems
- Requires ability and flexibility to work 10-hour shifts between the operational hours of 8am - 6pm Wednesday - Saturday, and provide occasional support on the weekends or other shifts
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.
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 .]