QA Incoming Inspection Specialist II

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 Med Tech, 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

Quality

Quality Assurance

Professional

Raritan, New Jersey, United States of America

Johnson & Johnson is currently seeking three Quality Assurance Incoming Specialist II. This position will be located in Raritan, NJ! 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 Med Tech, 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  Johnson & Johnson Innovative Medicine, 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. In this role, you will be providing quality releases of materials related to the production of CAR-T and viral vectors in a controlled cGMP environment.

You will act as a liaison with other internal quality organizations to standardize policies, practices and procedures to increase quality and compliance and champion increased awareness of quality related concerns.

• Responsible for incoming inspection/release of materials related to manufacturing of autologous CAR-T products and viral vectors for clinical trials and commercial operation
• Reviews, inspection, and disposition of all incoming materials for use of CAR-T and viral vector product manufacturing per inspection plan and record results to complete receipt process
• Review inspection documentation (C of A or other Material Certifications) for inbound materials.
• Review and inspect documentation in support of Final Product Shipments
• Generates inspection reports and non-conformances for failures
• Ensures non-conformances are investigated thoroughly and approved in a timely manner and appropriate corrective and preventive action plans are implemented
• Track investigations to ensure timely closure
• Provide Quality Oversight to Warehouse for cGMP compliance through spot checks/internal audits
• Support execution of technical protocols
• Participate in departmental or multi-functional, interdepartmental teams and meetings
• Support External/Internal Audits
• Provide quality oversight for incoming shipments of raw materials, working cell banks and consumables and outgoing shipments of viral vector drug substance.
• Author and revise Quality departmental documents.
• Review and approve controlled documents including standard operating procedures, master batch records, work instructions, protocols and reports, and technical studies.
• Participate in continuous improvement activities.
• Other duties may be assigned as necessary.

• A minimum of a Bachelor’s Degree is required, with a focused degree in Engineering, Science or equivalent technical field preferred.

• Minimum 2 years of industry experience in a regulated manufacturing environment, preferably in biotechnology or pharmaceutical industry.
• Knowledge and solid understanding of current Good Manufacturing Practices (cGMP) regulations and FDA/EU guidance
• Ability to be organized and capable of working in a team environment with a positive demeanor.
• A…