QC Clinical Release & Stability Specialist

NCSL International; Pennsylvania, United States, Northern America, Americas; Hybrid; USD 70,000 - 100,000; Full time

Job summary

Johnson & Johnson is seeking a QC Clinical Release & Stability (CRS) Analyst in Malvern, PA to perform analytical testing of cell and gene therapy products and related materials. The role ensures data quality, compliance with cGMP, and timely product releases.

You will collaborate with QA, manufacturing, and analytical development, maintain documentation in eLIMS and Empower, and support method transfers, investigations, and continuous improvement efforts.

Qualifications

• Bachelor's degree in Biology, Biochemistry, Microbiology, Chemistry, Biotechnology, or related field required.
• 3 years of laboratory experience in pharma/biotech or related industry.
• Familiarity with GMP and laboratory documentation practices.
• Experience with biological or analytical testing methods.

Responsibilities

• Perform analytical testing of drug substances, drug product, characterization, stability, and critical reagents.
• Execute assays such as Flow Cytometry, qPCR/ddPCR, ELISA, cell-based assays, endotoxin testing.
• Document testing activities per ALCOA+ and GMP requirements.
• Review data for accuracy and compliance; maintain records in approved systems.

Skills

GMP Knowledge

Lab Analysis

SOP Interpretation

Data Entry

Communication

MS Office

Education

Bachelor's degree in Life Sciences

Tools

eLIMS

MES

Empower

EDMS

Job description

Johnson & Johnson is seeking a QC Clinical Release & Stability (CRS) Analyst in Malvern, PA to perform analytical testing of cell and gene therapy products and related materials. The role ensures data quality, compliance with cGMP, and timely product releases.

You will collaborate with QA, manufacturing, and analytical development, maintain documentation in eLIMS and Empower, and support method transfers, investigations, and continuous improvement efforts.