Radiopharma Quality Assurance Specialist (Night Shift)

Cardinal Health, Inc.; Denver (CO); Vor Ort; USD 77.000 - 99.000; Vollzeit

Benefits dieser Stelle

Medical, dental and vision coverage

Paid time off plan

Health savings account (HSA)

401k savings plan

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

Zusammenfassung

Cardinal Health PET Manufacturing Services in Colorado is seeking a Quality Assurance professional to oversee CGMP documentation, product release, and cross-functional collaboration to ensure products and processes meet regulatory requirements.

The role emphasizes adherence to 21 CFR 212 CGMP, documentation control, and timely escalation of quality issues, with salary range disclosed and comprehensive benefits provided.

Qualifikationen

• Bachelor's of Science 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.
• Lifting: Frequent lifting 50-75 lbs.

Aufgaben

• Quality Assurance responsibilities include 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 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 and collaboration with operations department to drive quality system and CGMP requirements
• Responsible for product release activities per CGMP requirements
• Responsible for reporting quality system issues to the regional RQM. This includes timely escalation of discrepancies upon identification.

Kenntnisse

English communication

Regulated environment experience

Quality Assurance background

ISO experience

Pharmaceutical/medical device exposure

Lifting 50-75 lbs

Ausbildung

Bachelor's of Science degree preferred

Jobbeschreibung

Cardinal Health PET Manufacturing Services in Colorado is seeking a Quality Assurance professional to oversee CGMP documentation, product release, and cross-functional collaboration to ensure products and processes meet regulatory requirements.

The role emphasizes adherence to 21 CFR 212 CGMP, documentation control, and timely escalation of quality issues, with salary range disclosed and comprehensive benefits provided.