Clinical QC Release & Stability Specialist

Johnson Johnson; Malvern (Chester County); On-site; USD 85,000 - 110,000; Full time

Job summary

Johnson & Johnson in Malvern, PA is hiring a QC Clinical Release & Stability (CRS) Analyst. The role conducts analytical testing of cell and gene therapy products, ensuring cGMP compliance and timely data release.

Collaboration with QA, Manufacturing, and Analytical Development is required to support releases and investigations. Preferred candidates have 3+ years in a QC/analytical lab within pharma/biotech, familiarity with ALCOA+ documentation, and strong data integrity.

Qualifications

• Bachelor's degree required in a related scientific discipline.
• 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.
• Ability to interpret SOPs, test methods, protocols, and technical documents.
• Strong organizational, communication, and problem-solving skills.
• Proficiency with Microsoft Office and electronic laboratory systems.

Responsibilities

• Perform analytical testing of drug substances, drug product, characterization, stability, and critical reagent samples.
• Execute assays including Flow Cytometry, qPCR/ddPCR, ELISA, Cell-Based Assays, Endotoxin Testing and other methods.
• Ensure accurate and timely completion of testing activities per procedures and specs.
• Document testing activities per ALCOA+ and GMP requirements.
• Review laboratory data for accuracy, completeness, and compliance.
• Complete testing records, notebooks, electronic records, and reports in approved systems.
• Support laboratory investigations, deviations, CAPAs, and invalid assay assessments.

Skills

Analytical Reasoning

Compliance Management

Quality Control (QC)

Quality Standards

Data Analysis

Report Writing

Execution Focus

ISO 9001

Education

Bachelor's degree in Biology, Biochemistry, Microbiology, Chemistry, Biotechnology, or related scientific discipline

Job description

Johnson & Johnson in Malvern, PA is hiring a QC Clinical Release & Stability (CRS) Analyst. The role conducts analytical testing of cell and gene therapy products, ensuring cGMP compliance and timely data release.

Collaboration with QA, Manufacturing, and Analytical Development is required to support releases and investigations. Preferred candidates have 3+ years in a QC/analytical lab within pharma/biotech, familiarity with ALCOA+ documentation, and strong data integrity.