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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:

Janssen Pharmaceutical, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for Quality Control Analyst- Microbiology Lentiviral Vector (LVV)

At the Janssen Pharmaceutical Companies of Johnson & Johnson, 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 Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Biotech, Inc. is part of the Janssen Pharmaceutical Companies.

Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, 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 our pharmaceutical products? Apply today for this exciting opportunity!

The Microbiology Lentivirus Vector (LVV) Manufacturing QC Analyst is responsible for collaborating with the Operations Team to conduct environmental monitoring within the manufacturing facility. Additional responsibilities in the QC laboratory include environmental monitoring plate reads and endotoxin testing. They are responsible for ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations. They typically work with a team of 5 – 15 other Associates within the functional Quality Control laboratory and the Manufacturing area.

Key Responsibilities:

• Participate in LVV manufacturing facility commissioning and qualification.

• Perform Routine Environmental Monitoring of classified areas within the Raritan LVV Facility.

• Perform compressed gas sampling in the LVV manufacturing facility.

• Perform environmental monitoring plate reads.

• Perform endotoxin testing.

• Participate in gown qualification and requalification of personnel.

• Create, review and approve relevant QC documents, SOP’s and WI’s.

• Support Aseptic Process Simulations and visual inspection of components.

• Utilize electronic systems (eLIMS) for execution and documentation of testing. Perform peer data review/approval of laboratory data.

• Initiate quality investigations related to environmental monitoring.

• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.

Qualifications:

Education:

• Minimum of a Bachelor’s or equivalent degree required; focused degree in Biological Science or equivalent technical field preferred

Experience and Skills:

Required:

• Minimum two (2) years of relevant work experience

• Experience within the biological and/or pharmaceutical industry

• Microbiology experience related to manufacturing

• Detailed knowledge of Microbiology testing and sampling methods, techniques, and related equipment

• Aseptic processing in ISO 5 cleanroom and/or biosafety cabinets

• Knowledge of cGMP regulations

• Excellent written and verbal communication skills

• Highly organized and capable of working in a flexible team environment with a positive attitude under some supervision

Preferred:

• Experience in a Quality Control setting

• Experience working with cell therapy

• Knowledge of FDA/EU guidance relate