Night-Shift QA Specialist, CGMP Radiopharma

Regulatory Jobs; Denver (CO); On-site; USD 77,000 - 99,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off

Health savings account (HSA)

401k savings plan

Disability coverage

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Job summary

Cardinal Health PET Manufacturing Services in Denver, CO is seeking a Quality Assurance professional to support CGMP documentation review for product release, facilities, materials and processes. The role emphasizes compliance, safety and quality across operations.

Responsibilities include monitoring CGMP compliance, reporting metrics, ensuring regulatory alignment with 21 CFR 212, and collaborating with operations.

Qualifications

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

Responsibilities

• Quality Assurance responsibilities include CGMP documentation review for 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 the requirements of 21 CFR 212 (CGMP).
• Responsible for the quality of documentation (control, retention, and archival) to support CGMP activities.
• Engage with operations to drive quality system and CGMP requirements.
• Responsible for product release activities per CGMP requirements.
• Escalate discrepancies promptly to the regional RQM.

Skills

Quality systems

Regulatory knowledge

Investigations

Gap assessments

Quality metrics

Cross-functional collaboration

Education

Bachelor's degree

Job description

Cardinal Health PET Manufacturing Services in Denver, CO is seeking a Quality Assurance professional to support CGMP documentation review for product release, facilities, materials and processes. The role emphasizes compliance, safety and quality across operations.

Responsibilities include monitoring CGMP compliance, reporting metrics, ensuring regulatory alignment with 21 CFR 212, and collaborating with operations.