Quality Assurance Associate III

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

Job Function:
Quality

Job Sub Function:
Quality Assurance

Job Category:
Professional

All Job Posting Locations:
US004 PA Malvern - 200 Great Valley Pkwy

Job Description:

Johnson & Johnson Innovative Medicine, a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Assurance Associate III to support Quality Operations.

This position will be located in Malvern, PA.

At Johnson & Johnson Innovative Medicine, we are working to create a world without disease.

Transforming lives 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 Johnson & Johnson.

We collaborate with the world for the health of everyone in it.

Position Summary:

In this role, you will be responsible for providing quality oversight of the GMP Cell Banking Center of Excellence and affiliated laboratories including the cryofreezer storage room located at the Great Valley Parkway in Malvern, PA.  Additionally, you will be responsible for quality support of the QC Cell Banking laboratories at the Phoenixville Pike location in Malvern, PA.

 Primary responsibilities will include but are not limited to the Quality oversight of the production, testing, inventory, and supply of Master, Working, and Development Cell Banks for clinical, and commercial production as well as analytical testing for J&J biopharmaceutical and cell therapy products.  The candidate will act as a liaison with other internal and external quality organizations to standardize policies, practices, and procedures to increase quality and compliance and champion increased awareness of quality related concerns.

This position will also help guide the quality strategy to support the pipeline of cell banking testing and release requirements.

Main responsibilities will include, but are not limited to:


* Partner with Cell Banking GMP Operations team to provide Quality oversight to successfully manufacture cell line products and support processes in the cGMP facility. 


* Perform on the floor or desktop review of executed batch records and production documentation in support of batch release activities.  Provide guidance with real time manufacturing and/or documentation discrepancies.


* Review and approve controlled documents including standard operating procedures, master batch records, test reports, COAs, work instructions, cell bank ...