LEGEND BIOTECH USA Hiring For Qc Specialist Equipment Management, Car T at Raritan, NJ, United States , United States Full Time

Job Description

Description:

Legend Biotech is seeking a QC Specialist Equipment Management, CAR-T as part of our Quality Operations team based in Raritan, NJ.
Company Introduction
From the very beginning, we’ve been focused on the science. We came together as a team of experts, committed to quality, driven by excellence, and dedicated to experimentation. Though we faced many challenges, we remained fearless in our research and rigorous in our thinking, pushing ourselves to work harder. But what impacted us the most was the enormous burden patients’ bear and the difficulties they face, which drove us to think about what’s next.
We believe it’s time to accelerate and expand that transformation. At Legend Biotech, we are excited to bring clinical trials to patients in our pursuit of a cure. While we are focused on CAR-T in multiple myeloma, we firmly believe the prospects of cellular therapy stretch beyond just one disease or indication. The spark of hope is lit. At Legend Biotech, we’re using that hope to ignite the future of CAR-T cell therapy.
Strategic Collaboration
Legend Biotech USA Inc. and Janssen Biotech, Inc., one of the pharmaceutical companies of Johnson & Johnson, 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.
Role Overview
The QC Specialist Lab Services is responsible for equipment lifecycle management, and QC systems administration. The QC specialist is expected to work independently on routine tasks and have conceptual understanding of all Quality Control functions and business areas. May need supervision/support to resolve some complex issues. He/ She will serve as technical expert within job function. Thinks analytically and acts decisively.
Major Responsibilities

• Create URS and Manage equipment qualifications
• Support Data integrity assessment
• Lead Equipment Lifecycle Management (i.e., change control)
• Document and manage corrective and preventative action records
• Draft, review and approve equipment operational SOP
• Perform periodic review of system audit trails
• Manage equipment access and periodic reviews
• Troubleshoot analytical equipment related issues
• Support internal and regulatory audits

. Requirements:

• A minimum of a Bachelor’s Degree is required, preferably in Biology, Biochemistry, Microbiology Chemistry or related field
• A minimum of four (4) years related experience in medical device, biopharmaceutical or pharmaceutical industry.
• Working knowledge of regulatory requirements, policies and guidelines is preferred.
• Experience with Quality Control document reviews and regulatory inspection processes is preferred Working knowledge of Quality systems is preferred
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint), IMS, iLAB
• This position will occasionally require to lift up to 20 pounds.
• Candidates must be able to accommodate shift schedule. Shifts include routine weekend and evening work as required by the manufacturing process
• Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice.
• This position will be located in Raritan, NJ and may require up to 5% of travel.
• Capabilities, Knowledge, and skills: 1) Change control, 2) Instrument Qualifications, 3) Data Integrity and data backup, and 4) Bioanalytical Instrument Trouble shooting experiences (Flow Cytometer/Cell counters/PCR/plate readers etc)