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Janssen Pharmaceutical Inc. a member of Johnson & Johnsons 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 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 SOPs and WIs.

• 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 Bachelors 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 related to manufacturing of cell based products as well as knowledge of Good Tissue Practices (GTP)

• Trending using statistical analysis

Other:

• Requires ability to work in a cleanroom environment and ability to lift up to 20 pounds

• Requires ability and flexibility to accommodate unplanned overtime (including nights and weekends) on little to no prior notice

At Johnson & Johnson were on a mission to change the trajectory of health for humanity. That starts by creating the worlds healthiest workforce. Through cutting-edge programs and policies we empower the physical mental emotional and financial health of our employees and the ones they love. As such candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees their families and the communities in which we live and work.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness career and life journey please visit .

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