Quality Control Analyst, Critical Reagants

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Job Function:
Quality

Job Sub Function:
Quality Control

Job Category:
Professional

All Job Posting Locations:
Raritan, New Jersey, United States of America

Job Description:

Johnson & Johnson is currently recruiting for a Quality Control Analyst, CAR-T Critical Reagents! This position will be located in Raritan, NJ.

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.

Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in the manufacturing of our pharmaceutical products? Apply today for this exciting opportunity!

The Quality Control (QC) Analyst is responsible for preparing and conducting qualification testing of critical reagents used by the QC laboratories.

They are responsible for ensuring testing is completed in adherence with all applicable procedures, standards, and GMP regulations.

Key Responsibilities:


* Conduct analytical testing to qualify critical reagents used in the CAR-T QC laboratories


* Perform analytical testing in compliance with all applicable procedures, GMP, and GDP regulations


* Use eLIMS or paper records to document execution of testing


* Ensure a safe work environment by following guidelines in environmental, health, and safety regulations


* Perform peer review of laboratory data


* Prepare qualification documentation and issue Certificate of Analysis


* Author and updateSOPs, WIs, and Protocols using the Document Management System


* Support laboratory related investigation records and CAPAs


* Assist in the execution of internal audits


* Provide input to functional laboratory meetings


* Provide input and take actions as a QC representative at cross-functional meetings

Qualifications:
Education:
Minimum of a Bachelor's or equivalent University Degree requir...