Senior QA Associate – GMP Biotech (Hybrid/Travel)

Johnson & Johnson Co.; Malvern (Chester County); On-site; USD 80,000 - 110,000; Full time

Job summary

Johnson & Johnson is seeking a QA Associate III to lead quality oversight for GMP R&D GxP laboratories and support materials release across Malvern, PA with travel to Spring House, PA. The role emphasizes ensuring data integrity, regulatory compliance, and collaboration with R&D and Supply Chain to enable product development and release.

Responsibilities include overseeing laboratory operations, reviewing documents, and driving continuous improvement while maintaining inspection readiness and

Qualifications

• Bachelor's degree in engineering, biology, biochemistry, microbiology, chemistry or related field.
• At least 4 years in a regulated manufacturing environment, preferably biotech/pharma.
• Strong written records in paper and computerized systems.

Responsibilities

• Provide end-to-end quality oversight of GMP R&D GxP laboratories and warehouses.
• Review and approve raw material and critical reagent releases.
• Lead change controls and assess impact of proposed changes.
• Ensure data integrity and adherence to SOPs; support inspections and audit readiness.

Skills

Attention to detail

Communication

Project leadership

Independent worker

Education

Bachelor's degree in science/engineering

Tools

SAP

Maximo

Biovia/ eLIMS

Job description

Johnson & Johnson is seeking a QA Associate III to lead quality oversight for GMP R&D GxP laboratories and support materials release across Malvern, PA with travel to Spring House, PA. The role emphasizes ensuring data integrity, regulatory compliance, and collaboration with R&D and Supply Chain to enable product development and release.

Responsibilities include overseeing laboratory operations, reviewing documents, and driving continuous improvement while maintaining inspection readiness and