Senior QA Specialist — CGMP, Night Shift (Denver)

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

Benefits offered by this job

Medical, dental and vision coverage

401k savings plan

Paid time off

Health savings account (HSA)

Access to wages before pay day with my

Flexible spending accounts (FSAs)

Short- and long-term disability

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Job summary

Cardinal Health PET Manufacturing Services in the United States seeks a Quality Assurance professional to uphold CGMP standards, review documentation, and support product release in a radiopharmaceutical facility.

The role requires nights shift, a science degree, and 1–2 years QA/regulatory experience; ISO exposure is a plus, with cross-functional collaboration to ensure compliance and patient safety.

Qualifications

• Bachelor's degree in Chemistry or Biology preferred.
• Excellent 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.

Responsibilities

• Applies working knowledge in the application of concepts, principles, and technical capabilities to perform varied tasks.
• Works on projects of moderate scope and complexity.
• Identifies possible solutions to a variety of technical problems and takes actions to resolve.
• Applies judgment within defined parameters.
• Receives general guidance; may receive more detailed instruction on new projects.
• Work reviewed for sound reasoning and accuracy.

Skills

Attention to detail

English communication

Judgment and decision making

Problem solving

Cross-functional collaboration

Education

Bachelor's degree in Chemistry or Biology

Tools

ISO experience

CGMP documentation

Regulatory compliance

Job description

Cardinal Health PET Manufacturing Services in the United States seeks a Quality Assurance professional to uphold CGMP standards, review documentation, and support product release in a radiopharmaceutical facility.

The role requires nights shift, a science degree, and 1–2 years QA/regulatory experience; ISO exposure is a plus, with cross-functional collaboration to ensure compliance and patient safety.