Location: Raritan, NJ
Company: Johnson And Johnson
by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at and follow n Biotech, Inc.
is part of the Janssen medical Companies. Janssen Biotech, Inc. one of the Janssen medical 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 team that is positively impacting patients' lives by ensuring high quality in our medical products?
Apply today for this exciting opportunity! The QASF Associate II is responsible for on the floor quality oversight of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled c GMP cleanroom environment. Key Responsibilities: • Provide Oversight and Support to clean room activities. • Provider QA shop floor support (Grad-B/ISO-7) for extended periods of time. • Work with Process Development team and Operations organization to successfully
transfer process to c GMP facility to manufacture products. • Support drafting of standard operating procedures and batch records.
• Approve printed documents prior to use on the manufacturing floor. • Support on process aseptic process simulations of the processes to ensure sterility of the product/process is not compromised. • Real time review of all documentation and reporting in support of process unit operations. • Support material release in SAP for In-house reagents. • Ensure non-conformances are investigated thoroughly and approved in a timely manner and appropriate corrective and preventive action plans are implemented. • Strive to reduce non-conformances in supported areas by proactively driving compliance.
• Perform tasks in a manner consistent with the safety policies, quality systems and c GMP requirements. • Organization of Document Control room and preparation of completed Batch Records documents retransfers QA Document Control and Archival • Monitor warehouse, manufacturing, and manufacturing support activities for CG MP compliance through spot checks/internal audits. • Other duties will be assigned, as the need arises. • Support the Shop Floor Order review and Closure process for executed batches and In House reagents/intermediates.
• Responsibilities will include but not limited to tasks mentioned above. Education: Minimum of a bachelor's or equivalent University Degree required; focused degree preferred in Science, Biology/Biotechnology, Cell/Gene Therapy, or equivalent technical field. Required: • Minimum 2 years of relevant work experience. • Quality Assurance experience within medical or a related industry. • Knowledge and solid understanding of current Good Manufacturing Practices (c GMP) regulations and FDA/EU guidelines. • Highly organized, with demonstrated attention to detail and ability to follow the procedures with minimal direction.
• Strong interpersonal skills, positive mentality, and capability of working in a collaborative team environment. • Proficient verbal communication skills, with the ability to optimally summarize and present results. Preferred: • Experience with aseptic processing in ISO 5 clean room. • Knowledge of c GMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices. • Good written and verbal communication skills are required. • Ability to summarize and present results, and experience with team-based collaborations is a must.
• Ability to collaborate well with stakeholders, customers, and peers. • Ability to manage conflict and issues that arise with internal or external customers. • Ability to handle multiple tasks on same time. • Familiarity with SAP, MES (electronic batch records), Track Wise (quality event management), or equivalent systems. Other: Requires ability and flexibility to work 10-hour shifts between the operational hours of 7:30 AM - 6:00 PM/2:00PM-12:30 AM (Sunday-Wednesday/ Wednesday - Saturday), and provide occasional support including nights, weekends, or other shifts with little or no prior notice.
This position has an estimated annual salary of 61,000- 110,000. Requiresthe ability to meet the physical demands (lift to 20 lbs. stand or sit for extended periods of time in a clean room environment), to perform visual inspections of materials (color, appearance, particles, etc. ) and to document observations during manufacturing. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, interaction, interactionual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Quality Assurance (QA) jobs involve ensuring that products and services meet certain standards of quality before they reach the consumer. Those in QA roles are responsible for developing and implementing testing processes, inspecting products for defects and non-compliance, and analyzing quality data to drive improvements. A key characteristic of QA positions is the focus on preventing errors rather than just correcting them, which necessitates a proactive approach and attention to detail. Additionally, QA professionals often collaborate closely with production teams to foster a culture of quality throughout an organization.
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Quality Assurance (QA) jobs involve ensuring that products, services, or processes meet established standards of quality through systematic activities and measures. These roles typically focus on preventing defects, identifying potential issues, and implementing solutions to maintain quality consistency. Key features of QA positions include rigorous testing, meticulous attention to detail, and a commitment to continuous improvement. QA professionals work across various industries, from software development to manufacturing, to safeguard customer satisfaction and comply with regulatory requirements.
Quality Assurance (QA) jobs involve ensuring that products or services meet certain standards of quality before they reach the consumer. Individuals in QA roles are responsible for planning and implementing inspection processes, conducting tests, and analyzing the results to detect defects. They work to prevent errors and improve the overall quality of the final output. Key characteristics of QA jobs include attention to detail, a systematic approach to problem-solving, and a strong understanding of industry-specific regulations and quality standards. These professionals play a critical role in customer satisfaction and maintaining the reputation of a brand or company.
