Exp Anlst Quality Assurance - Johnson and Johnson : Job Details

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 Job Function: QualityJob Sub Function: Quality AssuranceJob Category:ProfessionalAll Job Posting Locations:Raritan, New Jersey, United States of AmericaJob Description:Job Description:Johnson & Johnson is currently recruiting for a CAR-T Specialist 3, Quality Assurance Microbiology. This position will be located in Raritan, NJ.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 [CAR-T is an innovative treatment, which uses the power of the patient's own immune system. A patient's T-cells are genetically modified to eliminate cancer cells. This ground-breaking technology provides hopeful prospects to patients where other therapies have failed or fail to provide adequate results.Janssen Biotech, Inc. entered into a global collaboration agreement with Legend Biotech to develop, manufacture and commercialize ciltacabtagene autoleucel (cilta-cel). Through our strategic partnership, we look to advance the promise of an immunotherapy in the treatment of multiple myeloma.The Microbiology Specialist, Quality Assurance will join the Quality Assurance workstream and be closely connected with Operations and Quality Control workstreams. You will have the opportunity to develop extensive knowledge in the highly innovative Advanced Therapy Medicinal Product manufacturing process and contribute to a significant impact on the health of our patients. This position will based at the CAR-T manufacturing facility in Raritan, NJ.]Key Responsibilities:

• Serve as an aseptic processing expert for CAR-T and train individuals on aseptic processing.
• Develop, track, maintain, and deliver accurate data, metrics, and reports to support CAR-T manufacturing environment locally and in collaboration with other global ATMP manufacturing sites.
• Explore opportunities to introduce emerging technological/digital solutions in Quality and drive these to implementation.
• Review and approve non-conformance investigations in your area of expertise.
• Identify risks and opportunities in relation to process, contamination, and cross-contamination associated with the manufacturing environment and drive follow up initiatives for improvement in close collaboration with operators, QA, QC and operations management.
• Ensure compliance with all regulatory requirements particularly in the pharmaceutical industry, health and safety requirements and environmental legislation and cGMP requirements.
• Act as a spokesperson for your area during health care inspections. ]

QualificationsEducation:A minimum of a Bachelor's degree is required with a focus in Biological Sciences such as Microbiology, Molecular Biology, Biochemistry, or a related field preferred.Experience and Skills:Required:

• Minimum 2-4years working experience in a GMP regulated environment.
• Solid understanding of aseptic manufacturing and aseptic controls.
• Excellent written and oral communication skills.

Preferred:

• [Proficiency in analytical skills such as data analysis and data visualization.
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint)
• Empowered professional who drives a Quality Mentality and can make well motivated pragmatic decisions on their own.
• Connect easily at all levels in the organization and lead by example.
• Demonstrate a steadfast work ethic and a passion for overcoming obstacles.

Other:

• This position is anticipated to have up to 10% traveDemonstrate a steadfast work ethic and a passion for overcoming obstacles.

Business hours are generally Monday- Friday 8:00 a.m. to 5:00 p.m, fully onsite at our Raritan, NJ office.Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law.We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ([email protected]) or contact AskGS to be directed to your accommodation resource.The anticipated base pay range for this position is :$77,000- $124,200Additional Description for Pay Transparency:Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below.