QC Clinical Release & Stability (CRS) Analyst

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.

We provide an inclusive work environment where each person is considered as an individual.

At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:
Quality

Job Sub Function:
Quality Control

Job Category:
Professional

All Job Posting Locations:
Malvern, Pennsylvania, United States of America

Job Description:

About MedTech

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness.

Learn more at https://www.jnj.com/medtech

We are searching for the best talent for QC Clinical Release & Stability (CRS) Analyst, located at Malvern, PA.

Purpose:

The QC Clinical Release & Stability (CRS) Analyst is responsible for performing analytical testing of cell and gene therapy products, critical reagents, and characterization samples in support of clinical and commercial manufacturing.

This role executes testing activities in compliance with current Good Manufacturing Practices (cGMP), laboratory procedures, and regulatory requirements while ensuring the timely release of high-quality data.

The CRS Analyst works collaboratively with Quality Assurance, Manufacturing, Analytical Development, and other cross-functional partners to support product release, method transfers, investigations, and continuous improvement initiatives.

This position requires strong technical expertise, attention to detail, critical thinking, and a commitment to quality and patient safety.

You will be responsible for:

Quality Control Testing


* Perform analytical testing of drug substances, drug product, characterization, stability, and critical reagent samples.


* Execute assays including, but not limited to: Flow Cytometry qPCR/ddPCR ELISA Cell-Based Assays Endotoxin Testing Other biochemical and microbiological methods as applicable


* Ensure accurate and timely completion of testing activities according to approved procedures and specifications.


* Document testing activities in accordance with ALCOA+ and GMP requirements.

Data Review and Documentation


* Review laboratory data for accuracy, completeness, and compliance.


* Complete testing records, notebooks, electronic records, and reports in approved sy...