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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 history reports, stability reports, technical study protocols and reports.
• Ensure all non-conformances are fully investigated per the Review and Approval process, effective corrective/preventive actions are implemented in a timely manner.
• Support site inspections and inspection readiness activities. Ensure Cell Banking COE, related laboratories and cryofreezer room are audit ready.
• Perform Quality oversight of GMP receipts related to the Cell Banking shipping process.
• Act as a change agent to increase quality understanding and maturity in the laboratories.
• Works independently on complex issues. Serves as subject matter expert within function area.
• May participate in process improvement activities including assessing current processes, providing improvement input and working with partners to implement changes or change controls.
• Proactively addresses issues in the organization and keeps management informed.
• Other duties may be assigned as necessary.

Qualifications

Education:

A minimum of a Bachelor’s Degree is required, preferably in Engineering, Science, or equivalent technical discipline.

Required:

• 6-8 years of experience, in a regulated manufacturing environment, preferably in biotechnology or pharmaceutical industry.
• Minimum of five years of experience with quality support in clinical or GMP manufacturing or support of laboratories is preferred.
• Ability to be organized and capable of working in a team environment with a positive attitude under minimal supervision.
• A high degree of accuracy and attention to detail, and excellent interpersonal, oral, and written communication skills.
• Act as a trainer and SME for new people in the organization. Can act as delegate for management in their area.
• Ability to maintain written records of work performed in paper-based and computerized quality systems.

Preferred:

• Experience in cell culture processing and Research & Development laboratories is preferred.
• Ability to work in a low bioburden or aseptic processing environment (Grade B or ISO 7) is preferred.
• Knowledge of cGMP regulations and FDA/EU guidance related to the manufacture of cell line products is preferred.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love.