Radiopharma Quality Assurance Specialist (CGMP)

Cardinal Health; Albuquerque (NM); On-site; USD 69,000 - 88,000; Full time

Benefits offered by this job

Health coverage

Paid time off

HSA

401k savings plan

Early wage access (myFlexPay)

FSAs

Disability coverage

Work-Life resources

Parental leave

Wellness programs

Job summary

Cardinal Health PET Manufacturing Services is seeking a Quality Assurance professional to support CGMP compliance and product release processes. You will review documentation, manage controls, and collaborate with operations to uphold quality systems and regulatory standards in a radiopharmaceutical manufacturing setting.

The role involves night shifts (roughly 9pm–9am, Sun–Fri) and requires strong English communication, analytical skills, and a background in QA within regulated environments.

Qualifications

• Bachelor's degree preferred
• Effective written and verbal English communication skills required
• 0-2 years' experience in a regulated environment preferred
• Pharmaceutical or medical device experience a plus
• ISO experience a plus
• Quality Assurance background preferred

Responsibilities

• CGMP documentation review related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production & process controls.
• Establish and report metrics related to products and processes as deemed necessary by the RQM.
• Ensure the site manufactures products to meet CGMP requirements.
• Engage with operations to drive quality system and CGMP requirements.
• Responsible for product release activities per CGMP requirements.

Skills

English communication

Night shift ability

QA background

Education

Bachelor's degree preferred

Job description

Cardinal Health PET Manufacturing Services is seeking a Quality Assurance professional to support CGMP compliance and product release processes. You will review documentation, manage controls, and collaborate with operations to uphold quality systems and regulatory standards in a radiopharmaceutical manufacturing setting.

The role involves night shifts (roughly 9pm–9am, Sun–Fri) and requires strong English communication, analytical skills, and a background in QA within regulated environments.