Quality Assurance System Specialist

Company: Disability Solutions
Location: Wilson
Posted on: February 5, 2025

Job Description:

Johnson & Johnson is currently seeking a Quality Assurance System Specialist to join our Johnson & Johnson Innovative Medicine Supply Chain organization located in Wilson, North Carolina.While this role will ultimately support the site operations located in Wilson NC, this role will also be required to support the project phase across both design & construction. For the project design phase, the role will require you to be present with our design teams in the Greater Philadelphia region. Once the design phase is completed, this role will support the construction and operational start-up of the site. For this, you will be required to be on site in Wilson, NC. Based on your current location the hiring team will work with you to determine travel and relocation arrangements. In steady state, we expect travel to be less than 10%.J&J is expanding our manufacturing capacity with $2 billion investment to support strong portfolio growth and continue delivering breakthrough innovation and transformational medicines for patients. The new facility will expand production of innovative biologic medicines in areas including oncology, immunology, and neuroscience. J&J's significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for our current portfolio of medicines and our future innovations.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.We are currently seeking a highly qualified individual to join our Quality System team as a Quality System Specialist at our new Large Molecule Drug Substance Manufacturing facility. In this key role, you will be responsible for carrying out tasks and projects related to Quality Systems activities as required by Good Manufacturing Practice (GMP). These activities include change control, nonconformance investigation, complaints and CAPA system, Specifications, Quality Agreements and Gap Assessments management within the scope of the organization, Training, Management review (QSMR), documentation management, annual product review and validation compliance activities, among others.Essential Job Duties and Responsibilities:

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• Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met following the J&J Standards.
• Partners with other Departments to ensure that compliance systems are implemented in an efficient manner.
• Develops and implements processes, procedures, forms, work instructions and tools related to the implementation of compliance systems at the site.
• Carries out tasks related to the administration of site nonconformance management, change control and training systems and its applicable Electronic Tracking System (ETS).
• Develops and implements processes, procedures and tools related to the implementation of compliance systems at the site.
• Assist Specifications, Quality Agreements and Gap Assessment management activities within the scope of the organization.
• Support Management review (QSMR), documentation management, annual product review and validation compliance activities, as required.
• Responsible for managing the assigned Quality Systems Metrics and supporting the implementation of all quality policies, procedures, and systems to assure compliance with Regulatory and Company requirements.
• Provides training in Good Documentation Practice (GDP) and GMP to site personnel as directed as directed by the Quality Systems Manager.
• Develops and maintains training materials for provision of GDP and GMP training to site personnel of applicable systems.
• Supports Inspection readiness at the site as Quality Systems SME.\r\r

Keywords: Disability Solutions, Wilson , Quality Assurance System Specialist, Other , Wilson, North Carolina