QA Specialist II

Johnson & Johnson is currently seeking a QA Specialist II to join our QA team 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 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/ .

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 oversight for daily activities related to the production of 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.

Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our pharmaceutical products? Apply today for this exciting opportunity!
Main Responsibilities will include, but are not limited to:


* Perform review and approval of completed batch records and production documentation in support of batch release activities including preparation of product release documentation.


* Partner with Operations teams to support production activities in a cGMP manufacturing facility.


* Provide quality oversight for incoming shipments of raw materials, working cell banks and consumables and outgoing shipments of viral vector drug substance.


* Ensure all non-conformances are fully investigated and effective corrective/preventive actions are implemented in a timely manner.


* 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.


* Perform regularly scheduled oversight of manufacturing activities in a controlled clean room environment.


* Supports site inspections and inspection readiness activities.

Ensure the site is audit ready.

Support data integrity efforts.


* Other duties may be assigned as necessary.

Education:


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

Skills & Expe...