Quality Assurance Specialist jobs in Somerset, NJ

Johnson & Johnson Family of Companies

Title: Quality Assurance Specialist 

Location: Raritan, NJ

Duration: 1 year

Benefits on offer for this contract position: Health Insurance, Life insurance, 401K and Voluntary Benefits

Please note that this is a contract role providing services to the Johnson & Johnson Family of Companies through external staffing partners of Kelly OCG. If you are selected for this role, you will be employed by a contract staffing supplier and will not be a member of the Johnson & Johnson Family of Companies.

Summary:

In this role you will provide on-site shop floor Quality oversight for site and process qualification activities for clinical and commercial product manufacturing. You will provide Quality oversight for Aseptic Processing on behalf of Janssen Pharmaceuticals at an externally contracted manufacturing facility.

Responsibilities:

• On-site shopfloor Quality oversight for site and process qualification activities and commercial product manufacturing for CAR-T at an external site.
• Support on-site quality oversight for day-to-day production activities, including deviation and CPA review, escalation of critical issues, batch record review, release support and change control.
• Support monitoring of EM quality performance and proactively identify risks.
• Influence and build relationship with internal and external partners to continuously enhance quality performance.
• Interface with other functions (Operations, Planning, Technical Operations, etc.) within Janssen as well as the external manufacturer.
• Apply cGMP regulations and other FDA and international requirements to all aspects of the position.

Qualifications:

• Bachelor’s Degree with a concentration in Engineering, Science, or an equivalent technical discipline
• Minimum of 6 years working in drug substance and/or pharmaceutical manufacturing
• Experience in Pharmaceutical Aseptic Manufacturing Operations and Quality Assurance
• Detailed knowledge of cGMPs related to Pharmaceutical Production.
• Strong interpersonal and written/oral communication skills.
• Ability to quickly process complex information and make critical decisions with limited information and in a complex and time-sensitive environment.
• Preferred Experience in Good Tissue Practices Experience in biologic/vaccine/cell culture products.