CAR-T Warehouse Process Specialist - Raritan New Jersey

Company: Disability Solutions
Location: Raritan, New Jersey
Posted On: 04/21/2024

Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a CAR-T Warehouse Process Specialist! 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 Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and Legend Biotech USA Inc., have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR-T platform and investigational treatment. Are you interested in joining a diverse team delivering outstanding results to our customers? Apply now for this exciting opportunity! The CAR T Warehouse Support Associate will provide technical expertise to help identify true root cause of investigations and assess product quality impact. This individual will provide technical support for the investigation and resolution of deviations and atypical events. They will recommend, own, and implement corrective/preventative measures aimed at improving compliance and reducing repeat occurrences ensuring consistent quality standards are maintained. Key Responsibilities:

• Follow up to resolve if corrective actions adequately addressed root cause of NC event.
• Report and track deviations, events and key process parameters and provides reports to management on trending, and status as requested.
• Identify and implement process improvements related to safety, environmental, quality, compliance, productivity, yield, and cost.
• Implement process improvements within the change control system.
• Recognize and act on potential compliance issues and opportunities for process changes/continuous improvement.
• Multi-task and prioritize projects with competing deadlines.
• Partner with cross functional teams and warehouse leadership to implement process improvements.
• Assure regulatory compliance and technical feasibility of proposed changes.
• Serve as project manager for the change process and provide coordination to ensure timely and compliant implementation of process improvements.
• Serves as Subject Matter Expert (SME) in preparation for and during internal and external regulatory audits (including FDA, EMEA).
• Review, edit, and approve SOP and Work Instruction revisions. More...

      

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