Quality Control Analyst, Critical Reagants

• Conduct analytical testing to qualify critical reagents used in the CAR-T QC laboratories
• Perform analytical testing in compliance with all applicable procedures, GMP, and GDP regulations
• Use eLIMS or paper records to document execution of testing
• Ensure a safe work environment by following guidelines in environmental, health, and safety regulations
• Perform peer review of laboratory data
• Prepare qualification documentation and issue Certificate of Analysis
• Author and update SOPs, WIs, and Protocols using the Document Management System
• Support laboratory related investigation records and CAPAs
• Assist in the execution of internal audits
• Provide input to functional laboratory meetings
• Provide input and take actions as a QC representative at cross-functional meetings

Qualifications:

• Minimum two (2) years of relevant work experience
• Knowledge of cGMP regulations and Good Documentation Practices (GDP)
• Experience performing one or more of the following cellular and/or molecular based techniques: qPCR, Flow Cytometry, ELISA, Cell Culture, and/or Potency assays
• Excellent written and verbal communication skills

• Experience in reagent qualification
• Experience in a Quality Control setting
• Experience within Biopharmaceutical or Pharmaceutical industry
• Basic knowledge of compendial (e.g., USP, EP, JP, etc.) requirements pertaining to their functional area of QC
• Work experience in Cell and/or Gene Therapy

• This is Monday-Friday shift role, hours are 8AM-4PM, subject to be adjusted in the even of business need, occasional support on the weekends or holidays
• May require up to 10% domestic travel to regional sites

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 https://www.jnj.com/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource.