Investigator Lenti

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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.

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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 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 Bachelors 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 & Johnsonisan 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 federalstateor local law. We actively seek qualified candidates who areprotectedveterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnsoniscommitted to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to requestan accommodation please email the Employee Health SupportCenter () or contactAskGSto be directed to your accommodation resource.

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