About Cardinal Health

Cardinal Health is a global, integrated healthcare services and products company connecting the world of healthcare. With over 48,000 employees across North America, Europe, and Asia, we provide pharmaceuticals, medical products, and supply chain solutions that improve patient outcomes and reduce costs. Our Nuclear & Precision Diagnostics division specializes in radiopharmaceuticals like PET imaging agents FDG and NaF, ensuring reliable supply for critical diagnostic scans. At our Louisville, KY PET facility, we uphold the highest standards of quality and safety in FDA-regulated manufacturing.

Role Overview

The Senior Specialist, Quality Assurance plays a pivotal role at Cardinal Health's Louisville PET manufacturing site, an FDA-regulated facility producing sterile liquid injection drugs for Positron Emission Tomography (PET) scans. This full-time position involves night shift hours (1:00am-9:00am Monday-Friday, with 1 weekend per month) to support 24/7 production oversight. You'll make critical quality review and product release decisions, ensuring all outputs meet stringent CGMP standards under 21 CFR 212. With an anticipated salary range of $68,500 - $88,020 USD, this role offers competitive pay, comprehensive benefits, and opportunities in a high-impact healthcare environment.

Why This Role Matters

In PET drug manufacturing, quality assurance is non-negotiable. Your expertise will safeguard product safety, efficacy, and regulatory compliance, directly impacting patient care worldwide through accurate diagnostic imaging.

Key Responsibilities

As Senior Specialist, Quality Assurance, you'll drive operational excellence through hands-on quality oversight. Core duties include:

• Handling CGMP documentation review for product release, facilities, equipment, materials, laboratory controls, packaging, labeling, and production processes.
• Establishing and reporting key metrics on products and processes as directed by the Regional Quality Manager (RQM).
• Ensuring the site adheres to 21 CFR 212 CGMP requirements for sterile injectables.
• Managing documentation quality, including control, retention, and archival to support all CGMP activities.
• Collaborating with operations to embed quality systems and CGMP best practices.
• Executing product release per CGMP protocols.
• Monitoring CAPA investigations, closing completed items, and escalating issues as needed.
• Performing aseptic process reviews with operations and documenting findings.
• Reporting quality system issues to RQM with timely discrepancy escalations.

Qualifications & Requirements

Cardinal Health seeks candidates with a blend of education, experience, and skills tailored to regulated manufacturing:

• 2-4 years of relevant experience, preferably in cGMP environments.
• Bachelor's degree in a related field (e.g., life sciences, pharmacy, engineering) or equivalent work experience.
• Proficiency in MS Excel and MS Word for data analysis and reporting.
• Strong interpersonal skills for cross-functional collaboration.
• Exceptional attention to detail in high-stakes documentation.
• Preferred: Night shift experience, filing system maintenance, project management, and prior cGMP exposure.

At this level, you'll apply working knowledge to moderate-scope projects, resolve technical issues within defined parameters, and receive general guidance on new initiatives. Work is reviewed for accuracy and sound reasoning.

Benefits & Perks

Cardinal Health invests in your well-being with industry-leading benefits:

• Comprehensive medical, dental, and vision coverage.
• Paid time off (PTO) plan for work-life balance.
• Health Savings Account (HSA) and Flexible Spending Accounts (FSAs).
• 401k savings plan with generous company match.
• myFlexPay for early wage access before payday.
• Short- and long-term disability coverage.
• Work-life resources, paid parental leave, and healthy lifestyle programs.

These perks support your health, financial security, and personal growth from day one.

Career Growth

Cardinal Health fosters advancement in quality assurance and beyond. This senior specialist role builds expertise in CGMP, PET manufacturing, and regulatory affairs, positioning you for promotions to Quality Manager, Regional Quality Lead, or compliance specialist positions. Internal mobility programs, leadership training, and mentorship accelerate your path in healthcare quality.

Why Join Us

Join a Fortune 500 leader at the forefront of precision medicine. In Louisville, KY, you'll contribute to life-saving PET diagnostics while enjoying a stable night shift schedule, competitive salary up to $88,020+, and robust benefits. Cardinal Health values diversity, innovation, and employee success—apply now to elevate your career in quality assurance.

Role FAQs

Q: What is the work schedule?
A: 1:00am-9:00am Monday-Friday, with one weekend per month.

Q: Is cGMP experience required?
A: Preferred, but 2-4 years of related experience or equivalent qualifies.

Q: What software skills are needed?
A: Proficiency in MS Excel and Word is essential.

Q: When does the application window close?
A: Anticipated 3/28/2026—apply ASAP.

Q: Are bonuses offered?
A: No, but comprehensive benefits provide strong total rewards.