Analyst Quality Control

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Janssen Pharmaceuticals Inc. a member of Johnson & Johnsons 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 Bachelors 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 within 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 SOPs 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

• Requires up to 5% domestic travel to other sites/locations

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Johnson & Johnson is an 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 disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

#car-t

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