Job Description
This job is with Johnson & Johnson, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. 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 jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function Supply Chain Manufacturing Job Sub Function Manufacturing Pharmaceutical Process Operations Job Category Professional All Job Posting Locations: Raritan, New Jersey, United States of America Job Description About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine Janssen Pharmaceuticals, Inc., part of the Johnson & Johnson Family of Companies, is recruiting for a Investigator - Lenti, located in Raritan, NJ. Summary The Investigator will lead cross-functional investigations teams to identify true root cause of investigations, conduct risk assessments, and assess the impact of nonconformances. This individual will perform investigation and identify resolution for deviations and atypical events. They will recommend and coordinate implementation for corrective/preventative measures to improve compliance and ensure consistent quality standards are maintained. Key Responsibilities Conduct root cause analysis investigations and author nonconformance reports. Identify and implement process improvements related to safety, environmental, quality, compliance, efficiency, yield, and cost. Recognize and act on potential compliance issues and opportunities for process changes/improvement. Assure regulatory compliance and technical feasibility of proposed changes. Serves as Subject Matter Expert (SME) in preparation for and during internal and external regulatory audits (including FDA, EMEA). Coordinate data collection and trend analysis as requested by QA and Regulatory Affairs. Qualifications Education: A minimum of a Bachelor's degree is required, focus degree in Engineering and/or Life Science is preferred. Experience And Skills Required: Minimum 2 years of relevant work experience Ability to read, analyze, and interpret procedure manuals, common scientific / technical journals, basic financial reports and legal documents, general business periodicals, and government regulations Excellent written and oral communication skills to respond to critical inquiries or complaints from managers, regulatory agencies, or members of the business community Experience within Cell/Gene therapy, Biopharmaceutical, or Pharmaceutical industry Preferred Experience with one or more of the following enterprise systems: eLIMS, Comet Salesforce, Maximo, EMS, BMS, and/or SAP Experience with internal and/or external regulatory audits Experience with quality investigations, including root-cause analysis of nonconformance events Demonstrated ability to effectively use software applications for data entry, data analysis, word processing, presentations, and calculations 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 vet