Senior Specialist, Quality Assurance (Nights)

Quality Assurance

Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Assurance develops and implements a compliant and cost effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production / manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented.

Cardinal Health PET Manufacturing Services is responsible for manufacturing PET radiopharmaceuticals to enhance patient treatment through improved disease diagnosis, staging, and monitoring.

Responsibilities

• Handles CGMP documentation review related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production & process controls.
• Establishes and reports 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).
• Handles and ensures quality of documentation (control, retention, and archival) to support CGMP activities
• Engage and collaborate with operations department to drive quality system and CGMP requirements
• Performs product release activities per CGMP requirements
• Report quality system issues to the Regional Quality Manager. This includes timely escalation of discrepancies upon identification.

Location / Schedule

Qualifications

Work Environment

What is expected of you and others at this level

Anticipated salary range : $67,500-$96,400

Bonus eligible : No

Benefits : Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

Application window anticipated to close : 2 / 1 / 2025

The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity.

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply. Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity / expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.