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-Pacific, we provide pharmaceuticals, medical products, and services that enhance patient outcomes. Our PET Manufacturing Services division specializes in producing PET radiopharmaceuticals, critical for advanced disease diagnosis, staging, and monitoring. At our state-of-the-art Beltsville, MD facility, we maintain rigorous standards in a controlled environment handling radioactive materials safely under federal and state regulations.

Role Overview

The Sr. Quality Assurance Specialist (Nights) plays a pivotal role in upholding the integrity of our PET radiopharmaceutical production. This full-time night position, typically Monday through Friday from 1:30 am to 9:30 am, requires flexibility for shifting schedules based on business needs. You'll work in a clean, orderly manufacturing pharmacy with low to moderate noise levels, ensuring products meet stringent CGMP standards under 21 CFR 212. With an anticipated salary range of $76,700 - $98,550, this role offers stability and impact in the healthcare sector.

Key Environment Details

Employees handle safe, low-level radiation with comprehensive training and monitoring. The facility operates under strict oversight from corporate quality teams, state, and federal agencies, prioritizing safety and compliance.

Key Responsibilities

In this position, you'll drive quality excellence through hands-on involvement:

• Review CGMP documentation for product release, facilities, equipment, materials, lab controls, packaging, labeling, and production processes.
• Develop and report metrics on products and processes as directed by the Regional Quality Manager (RQM).
• Ensure manufacturing adheres to 21 CFR 212 CGMP regulations.
• Oversee documentation quality, including control, retention, and archival for CGMP activities.
• Collaborate with operations to embed quality systems and CGMP requirements.
• Execute product release per CGMP protocols and escalate discrepancies promptly to RQM.

Qualifications & Requirements

We seek detail-oriented professionals with a strong foundation in quality assurance:

• Bachelor’s degree in a science field (Microbiology, Chemistry, Biology, Physics) or equivalent experience preferred.
• 2+ years in a related science field.
• 1-2 years in Quality Assurance or regulated environments, especially cGMP.
• Pharmaceutical, medical device, or ISO experience advantageous.
• Strong written and verbal English communication.
• Physical capability to lift up to 75 lbs.
• Ability to manage multiple tasks, exercise judgment, and work under general guidance.

Expected Performance Level

Apply working knowledge to moderate-scope projects, identify solutions to technical problems, and receive review for accuracy. Personal Protective Equipment (PPE) is provided and required.

Benefits & Perks

Cardinal Health invests in your well-being with comprehensive offerings:

• Medical, dental, and vision coverage.
• Paid time off (PTO) plan.
• Health Savings Account (HSA).
• Extensive programs supporting health, wellness, and work-life balance.
• Training for radiation safety and CGMP compliance.

No bonus eligibility, but robust benefits ensure long-term security.

Career Growth

Advance within Cardinal Health's dynamic environment. This senior specialist role builds expertise in quality systems, opening doors to managerial positions in regulatory affairs, operations, or corporate quality. Cross-functional collaboration hones leadership skills, with opportunities for certifications in cGMP, ISO, or Six Sigma. Our PET division supports cutting-edge healthcare innovation, positioning you for impactful career progression.

Why Join Us

Be part of a mission-driven team revolutionizing patient care through reliable radiopharmaceuticals. Enjoy a supportive culture emphasizing safety, compliance, and excellence. Night shift premiums and flexibility reward dedication, while Beltsville's location offers proximity to DC metro amenities. Cardinal Health values diverse talent, fostering inclusion and professional development in a premium healthcare leader.

Role FAQs

Q: What is the exact shift?
A: Typically 1:30 am - 9:30 am, Monday-Friday, 40 hours/week, with flexibility for business needs.

Q: Is radiation exposure safe?
A: Yes, low levels monitored routinely with training to stay within guidelines.

Q: What experience is most valued?
A: cGMP in pharma or regulated settings; science degree preferred.

Q: Are there physical demands?
A: Ability to lift 75 lbs and work in a cleanroom environment with PPE.

Q: How does this role impact patients?
A: Ensures safe, effective PET products for disease diagnosis and treatment.

Join Cardinal Health today and elevate quality in healthcare. Apply now for this Sr. Quality Assurance Specialist (Nights) role in Beltsville, MD.