Senior QA Specialist - CGMP & Regulatory Night Shift

Cardinal Health; Colton (CA); On-site; USD 77,000 - 99,000; Full time

Benefits offered by this job

Health benefits

401k savings plan

Paid time off

HSA

Job summary

Cardinal Health PET Manufacturing Services emphasizes quality assurance across CGMP documentation, product release, facilities, equipment, and production controls. This role supports cross-functional collaboration to maintain regulatory compliance and robust quality systems in a radiopharmaceutical environment.

The position requires a science degree, QA experience, and strong communication skills, with exposure to CGMP and regulatory standards.

Qualifications

• Bachelor's of Science in Chemistry or Biology degree preferred.
• Effective written and verbal English communication skills required.
• 1-2 years experience in QA and/or regulated environment highly preferred - cGMP.
• Pharmaceutical or medical device experience a plus.
• ISO experience a plus.
• Quality Assurance background preferred.

Responsibilities

• Apply working knowledge to varied tasks within a QA context.
• Work on projects of moderate scope and complexity.
• Identify solutions to technical problems and take action.
• Exercise judgment within defined parameters.
• Receive general guidance and follow detailed instructions on new projects.
• Ensure sound reasoning and accuracy in work.

Skills

Quality Assurance experience

cGMP knowledge

Regulated environment experience

English communication

Education

Bachelor's of Science in Chemistry or Biology

Tools

ISO experience

Job description

Cardinal Health PET Manufacturing Services emphasizes quality assurance across CGMP documentation, product release, facilities, equipment, and production controls. This role supports cross-functional collaboration to maintain regulatory compliance and robust quality systems in a radiopharmaceutical environment.

The position requires a science degree, QA experience, and strong communication skills, with exposure to CGMP and regulatory standards.