CAR-T QC Analyst: Critical Reagents Specialist

Biopharma Careers; Raritan (NJ); Vor Ort; USD 65.000 - 105.000; Vollzeit

Zusammenfassung

Johnson & Johnson is recruiting a Quality Control Analyst, CAR-T Critical Reagents, in Raritan, NJ. The role focuses on qualifying critical reagents for CAR-T QC labs, ensuring testing aligns with cGMP and GDP standards and regulatory requirements.

The qualified candidate will perform analytical testing, document results, assist in audits, and contribute to cross-functional QC initiatives. This is a Monday–Friday day shift with potential travel as needed.

Qualifikationen

• Minimum 2 years of relevant work experience.
• Knowledge of cGMP and GDP practices.
• Experience with qPCR, Flow Cytometry, ELISA, Cell Culture and/or potency assays.
• Excellent written and verbal communication skills.

Aufgaben

• Conduct analytical testing to qualify critical reagents used in CAR-T QC laboratories.
• Perform testing in compliance with GMP and GDP regulations.
• Document testing with eLIMS or paper records.
• Prepare qualification documentation and issue COA.
• Author and update SOPs, WIs, and Protocols.
• Support investigation records and CAPAs; assist internal audits.
• Represent QC in cross-functional meetings and provide input.

Kenntnisse

Two+ years experience

cGMP knowledge

GDP knowledge

qPCR

Flow Cytometry

ELISA

Cell Culture

Potency assays

Excellent communication

Ausbildung

Bachelor's degree in Biology/biochemistry/related field

Jobbeschreibung

Johnson & Johnson is recruiting a Quality Control Analyst, CAR-T Critical Reagents, in Raritan, NJ. The role focuses on qualifying critical reagents for CAR-T QC labs, ensuring testing aligns with cGMP and GDP standards and regulatory requirements.

The qualified candidate will perform analytical testing, document results, assist in audits, and contribute to cross-functional QC initiatives. This is a Monday–Friday day shift with potential travel as needed.