Quality Control Analyst- Microbiology LVV

Johnson & Johnson•Raritan, NJ

5d•$65,000 - $104,650•Onsite

About The Position

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.

Requirements

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

Nice To Haves

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

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.

Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year