Senior Investigator, MS&T

Company: Disability Solutions
Location: Raritan
Posted on: September 28, 2024

Job Description:

Johnson & Johnson is currently seeking a Sr. Investigator MS&T to join our TEAM!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 https://www.jnj.com/.For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential. At Johnson & Johnson, we all belong.Are you interested in making a difference in a growing company thriving on a diverse culture, celebrating the uniqueness of our employees, and committed to inclusion? Apply today for this phenomenal opportunity!The Sr. Investigator will be part of the site MS&T team and will be responsible for the investigations of manufacturing deviations, implementing applicable corrective and preventive actions in accordance with our company regulations and other global health authority regulators such as FDA. Will collaborate cross functionally to close nonconformance records and identify vital corrections.Key Responsibilities:

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• Lead cross functional investigations independently end to end.
• Ensure thorough root cause analysis, impact assessment, and corrective action determination.
• Serve as Subject Matter Expert (SME) in preparation for and during internal and external regulatory audits (including FDA, EMEA).
• Support coordination of data collection and trend analysis as requested by QA and Regulatory Affairs including the annual report and continued process verification (CPV)
• Recognize and act on potential compliance issues and opportunities for process changes/improvement.
• Provide technical expertise in the site MS&T group, with a focus on process knowledge of the cell and gene therapy manufacturing, including but not limited to deviations (Quality Issues), investigations, corrective action management.
• Work cross functionally with SME's and Quality to ensure robustness of investigations, as well as accuracy and ensuring compliance.
• An ability to build strong partnerships and effectively integrate with collaborators to drive projects/programs forward in a matrixed environment\r\r

Keywords: Disability Solutions, New Brunswick , Senior Investigator, MS&T, Other , Raritan, New Jersey