Analyst Quality Control

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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 Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for an Analyst, Quality Control Analytics - CAR-T in Raritan, NJ! This shift is going to be scheduled 8:00am - 6:00pm Sunday
- Wednesday.

Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our cell therapy products? Apply today for this exciting opportunity to be part of the #CAR-T team!

The QC Analyst is responsible for conducting biochemical, microbiological, and/or general testing of final product samples submitted to the QC laboratories. 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 Analysts within the functional laboratory of the Quality Control department.

Key Responsibilities:

• Perform analytical testing and maintain a safe work environment in compliance with all applicable procedures, EHS, and GMP regulations
• Perform peer review/approval of laboratory data and logbooks
• Use electronic systems (e.g., LIMS, iLAB) for execution and documentation of testing
• Build, review, and approve relevant QC documents, SOPs, and WIs
• Complete invalid assay and general laboratory investigation records, CAPAs, change controls
• Support Health Authority inspections
• Provide input to functional laboratory meetings

Qualifications:

Education:

• Minimum of a Bachelor's or equivalent University Degree required; advanced degree (MSc., Ph.D.) or focused degree in Biology, Biochemistry, Chemistry, or related scientific field is preferred

Experience and Skills:

Required:

• Minimum of two (2) years of relevant work experience
• Experience performing one or more of the following cellular and/or molecular based techniques: qPCR, Flow Cytometry, ELISA, Cell Culture, and/or Potency assays
• Experience with in Biopharmaceutical or Pharmaceutical industry
• Experience with aseptic processing in biosafety cabinets and/or ISO 5 clean room
• Demonstrated experience successfully working in an analyst role/level and proficiency using analytical methodologies within a functional laboratory
• Knowledge of cGMP regulations and Good Documentation Practices (GDP)
• Experience with Quality Control document reviews and regulatory inspection processes
• Proficient in performing technical writing (e.g., test methods, SOP's, protocols, etc.)
• Excellent written and verbal communication skills

Preferred:

• Work experience in Cell and/or Gene Therapy or Biologics
• Basic knowledge of Compendial (e.g., USP, EP, JP, etc.) requirements and standards
• Experience with LIMs and SAP or equivalent systems
• Experience, training, or certification with Process Excellence tools and methodologies

Other:

• Requires ability and flexibility to work 10-hour shifts between the operational hours of 8:00am - 6:00pm (Sunday - Wednesday), and provide occasional support on the weekends or other shifts
• Requires the ability to meet the physical demands (lift up to 20 lbs, stand or sit for extended periods of time in a laboratory setting), to perform visual inspections of materials (color, appearance, particles, etc.), and to document observations during laboratory testing
• Require…