QA Lab Oversight Specialist II

Company: Disability Solutions
Location: Raritan
Posted on: September 20, 2024

Job Description:

Johnson & Johnson is recruiting for a QA Lab Oversight Specialist, 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/.The QA Lab Oversight role is an exempt level position with responsibilities for providing quality oversight for Raritan site Quality Control laboratories. The responsibility includes providing quality support for pre-clinical, clinical, and commercial stage CAR-T cellular therapy product quality control testing.Key Responsibilities:

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• Provides quality oversight for site Quality Control laboratories responsible for testing clinical and commercial stage CAR-T cellular therapy products in accordance with local site and global J&J policies.
• Work with QC organization to support the successful transfer of QC Lab functions to the Raritan cGMP facility to test products.
• Review and approve GMP documents as applicable.
• Support the release of patient sample materials.
• Perform spot-checks in the QC Laboratories to ensure compliance.
• Strive to reduce non-conformances in supported areas by proactively driving compliance.
• Recognize patterns/trends in shop floor behaviour, reported data and communicate to management trending issues for improvement opportunities.
• Provide mentorship to other employees in the interpretation of quality issues and participates in the development of technical or scientific initiatives and activities.
• Support the timely closure of quality issues.
• Act as liaison for the quality team to guide project and strategy execution.
• Learn and develop within the business as a Subject Matter Expert on quality assurance topics.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.\r\r\r

Keywords: Disability Solutions, New Brunswick , QA Lab Oversight Specialist II, Healthcare , Raritan, New Jersey