Night-Shift Radiopharma QA Specialist | CGMP

Regulatory Toolkit; Albuquerque (NM); Presencial; USD 69 000 - 88 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical, dental and vision coverage

Paid time off

401k

Health savings account

MyFlexPay

FSAs

Disability coverage

Paid parental leave

Wellness programs

Resumo da oferta

Cardinal Health PET Manufacturing Services in Albuquerque is seeking a Quality Assurance professional to support CGMP product release and documentation controls. You will ensure compliance with 21 CFR 212, develop and monitor metrics, and cooperate with operations to strengthen the quality system.

Candidates should have a BS in science and good English communication; night shift availability (roughly 9pm–9am, Sun–Fri) is required, with training on radiation safety and CGMP at the facility.

Qualificações

• Bachelor's degree in science is preferred.
• Strong written and verbal English communication required.
• Experience in regulated environments is a plus.
• Quality Assurance background is advantageous.

Responsabilidades

• CGMP documentation review related to product release and controls.
• Establish and report metrics for products and processes.
• Ensure site CGMP compliance per 21 CFR 212.
• Manage quality documentation control, retention and archival.
• Collaborate with operations to drive quality system requirements.
• Oversee product release activities per CGMP.
• Escalate discrepancies to the regional RQM promptly.

Conhecimentos

English communication

Root cause analysis

CAPA

Quality systems

Cross-functional work

Good judgment

Formação académica

Bachelor's degree in science

Ferramentas

CGMP documentation

Descrição da oferta de emprego

Cardinal Health PET Manufacturing Services in Albuquerque is seeking a Quality Assurance professional to support CGMP product release and documentation controls. You will ensure compliance with 21 CFR 212, develop and monitor metrics, and cooperate with operations to strengthen the quality system.

Candidates should have a BS in science and good English communication; night shift availability (roughly 9pm–9am, Sun–Fri) is required, with training on radiation safety and CGMP at the facility.