# QC Clinical Release & Stability (CRS) Analyst at Johnson & Johnson

Johnson & Johnson is hiring a QC Clinical Release & Stability (CRS) Analyst. Level rates it Little AI ●○○○; you can [apply on Level](https://jobsbylevel.com/go/3d17819d-cc0e-46a4-8821-0c699d4e2a27).

AI Level 1, AI centrality 34 out of 100. Malvern, Pennsylvania, United States of America.

## Details

- Company: [Johnson & Johnson](https://jobsbylevel.com/companies/johnson-johnson)
- AI level: AI Level 1 (score 34 out of 100)
- Location: Malvern, Pennsylvania, United States of America
- Posted: October 9, 2026
- Apply: https://jobsbylevel.com/go/3d17819d-cc0e-46a4-8821-0c699d4e2a27

## Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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 systems such as eLIMS, MES, Empower, and EDMS. Support laboratory investigations, deviations, CAPAs, and invalid assay assessments. Maintain training records and remain qualified on assigned analytical methods. Method Transfer and Continuous Improvement Support new product introductions (NPI), method qualification, validation, and technology transfer activities. Participate in implementation of new methodologies, instrumentation, and laboratory technologies. Contribute to process optimization, digital transformation initiatives, and business excellence projects. Identify opportunities to improve efficiency, compliance, and data integrity. Laboratory Operations Maintain laboratory equipment through routine calibration, maintenance, and troubleshooting activities. Manage laboratory inventory, reagents, and consumable supplies. Ensure laboratory areas remain inspection-ready and compliant with safety standards. Participate in internal audits, regulatory inspections, and compliance initiatives. Collaboration and Leadership Partner with Quality

The description is cut here. Read the full offer: https://jobsbylevel.com/jobs/qc-clinical-release-stability-crs-analyst-at-johnson-johnson-64723a

Source: https://jobsbylevel.com/jobs/qc-clinical-release-stability-crs-analyst-at-johnson-johnson-64723a

## Cite this page

Level. https://jobsbylevel.com/jobs/qc-clinical-release-stability-crs-analyst-at-johnson-johnson-64723a.

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