About Cardinal Health

Cardinal Health, a global leader in healthcare services and products, empowers pharmacies, hospitals, and healthcare providers with innovative solutions that improve patient outcomes. With a presence across the United States and beyond, Cardinal Health specializes in pharmaceutical manufacturing, supply chain management, and specialized therapies like theranostics. Our Indianapolis Theranostics Commercial facility represents cutting-edge work in radiopharmaceuticals, where quality assurance plays a pivotal role in delivering safe, effective products. Join a Fortune 500 company committed to excellence, compliance, and innovation in the medical supply chain.

Role Overview

The Principal Specialist, Quality Assurance position at Cardinal Health's Indianapolis, IN facility is a critical role within our Theranostics Commercial operations. Reporting to the Manager, Quality Assurance, this expert-level position ensures that all manufacturing processes meet the highest GMP, FDA, and EU regulatory standards. With a salary range of $79,700 - $113,800 USD annually, this full-time role offers the opportunity to oversee product inspections, champion compliance, and drive continuous improvement in a dynamic radiopharmaceutical environment. Ideal for seasoned QA professionals passionate about quality in healthcare manufacturing.

Key Focus Areas

This role emphasizes hands-on inspection of in-process and finished products, raw material dispositioning, and collaboration with manufacturing teams to uphold radiation safety and EHS practices. As a Principal Specialist, you'll mentor colleagues, approve minor quality events, and contribute to GMP training programs, making a direct impact on product reliability and patient safety.

Key Responsibilities

In this position, you'll take ownership of quality monitoring from raw materials to final release. Core duties include:

• Conducting thorough inspections and sampling throughout the manufacturing process to verify compliance with specifications.
• Establishing and maintaining robust quality control procedures, including test types, documentation, and reporting standards.
• Interacting with manufacturing and service teams to set quality benchmarks for raw materials, work-in-process, and finished products.
• Championing GMP compliance, GDP requirements, EHS, and Radiation Safety practices across the facility.
• Developing and leading comprehensive GMP/GDP training programs while mentoring operational staff.
• Partnering with plant management to troubleshoot deficiencies, implement corrective actions, and prevent quality issues.
• Assisting in final product release in line with FDA, EU regulations, and marketing authorizations.
• Reviewing and dispositioning incoming raw materials and components for compliance.
• Managing quality events to ensure timely, accurate resolution per quality agreements, with authority to approve minor events.
• Networking across business units to drive positive outcomes and continuous improvement in the GMP Quality Management System.

Qualifications & Requirements

To succeed as Principal Specialist, Quality Assurance, candidates should demonstrate:

• A Bachelor’s degree in a related field such as biology, chemistry, engineering, or equivalent professional experience. An advanced degree is preferred.
• 4-8 years of hands-on experience in quality assurance, preferably in pharmaceutical or radiopharmaceutical manufacturing.
• Deep knowledge of GMP, GDP, FDA, and EU regulations, with proven ability to handle complex technical and compliance challenges.
• Strong analytical skills for root cause analysis, problem-solving, and evaluating product quality impacts.
• Excellent communication and mentoring abilities to train staff and collaborate cross-functionally.
• Ability to work independently on large-scope projects, innovate solutions, and escalate issues appropriately.

At this senior level, you'll apply comprehensive expertise to develop policies, mentor juniors, and deliver results with minimal supervision, aligning with Cardinal Health's objectives.

Benefits & Perks

Cardinal Health invests in your well-being with a comprehensive benefits package designed for full-time employees:

• Competitive medical, dental, and vision coverage.
• Generous paid time off plan and paid parental leave.
• 401k savings plan with company matching.
• Health savings account (HSA) and flexible spending accounts (FSAs).
• Access to wages before payday via myFlexPay.
• Short- and long-term disability coverage.
• Work-life resources and healthy lifestyle programs.

These perks support your professional and personal growth in a supportive, innovative environment.

Career Growth

Cardinal Health fosters career advancement through mentorship, training, and exposure to high-impact projects. As a Principal Specialist, you'll gain expertise in theranostics—a fast-growing field in precision medicine—positioning you for leadership roles in quality management, regulatory affairs, or operations. Our commitment to continuous improvement and internal mobility ensures long-term opportunities within our global network.

Why Join Us

At Cardinal Health, you'll contribute to life-saving therapies in a state-of-the-art Indianapolis facility. Enjoy a collaborative culture, premium compensation up to $113,800 USD (with estimated upside potential), and benefits that prioritize your health. Be part of a team that champions quality, safety, and innovation in healthcare. This role offers stability, impact, and growth in the thriving medical supply chain sector.

Role FAQs

Q: What is the reporting structure?
A: Reports directly to the Manager, Quality Assurance.

Q: Is travel required?
A: Primarily on-site in Indianapolis, IN, with potential for cross-functional networking.

Q: What makes this role unique?
A: Focus on theranostics manufacturing, involving radiation safety and advanced GMP in radiopharmaceuticals.

Q: Are bonuses offered?
A: This role is not bonus-eligible but includes robust benefits.

Q: How does Cardinal Health support professional development?
A: Through GMP training leadership, mentoring opportunities, and access to continuous improvement initiatives.