Chemical/Pharmaceutical, Quality Assurance (NIGHTS)

Cardinal Health; Denver (CO); On-site; USD 77,000 - 99,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Paid time off

HSA

401k plan

MyFlexPay access

FSAs

Disability coverage

Wellness program

Parental leave

Job summary

Cardinal Health PET Manufacturing Services in Denver is seeking a Quality Assurance professional to ensure CGMP documentation and product release meet regulatory requirements.

You will collaborate with operations to drive quality systems, conduct investigations, and implement corrective actions while maintaining compliance with 21 CFR 212.

The role requires strong English communication and a background in QA within pharma or medical devices; ISO experience is a plus.

Qualifications

• Bachelor's of Science degree preferred.
• Effective written and verbal English communication 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.

Responsibilities

• Applies working knowledge to perform varied tasks.
• Works on projects of moderate scope and complexity.
• Identifies solutions to technical problems and resolves them.
• Applies judgment within defined parameters.
• Work is reviewed for sound reasoning and accuracy.

Skills

English communication

Quality Assurance concepts

Education

Bachelor's of Science degree preferred

Job description

About the Role

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

Quality Assurance Contributions

• Developing and implementing a compliant and cost effective quality system that assures products and services are reliable, safe and effective
• Demonstrates knowledge of quality systems and approaches
• Demonstrates an understanding of the relevant regulations, standards and operating procedures
• Demonstrates ability to perform investigations / root cause analysis and develop corrective actions
• Demonstrates an understanding of the requirements and has the ability to perform gap assessments to those requirements
• Demonstrates an understanding of quality concepts such as: cost of quality, analytical metrics and / or statistics, trending, quality planning, validation, CAPA and problem solving
• Works cross-functionally and has the ability to interpret the requirements as well as educate and influence others on those requirements

What is Expected of You and Others at this Level

• Applies working knowledge in the application of concepts, principles, and technical capabilities to perform varied tasks
• Works on projects of moderate scope and complexity
• Identifies possible solutions to a variety of technical problems and takes actions to resolve
• Applies judgment within defined parameters
• Receives general guidance; may receive more detailed instruction on new projects
• Work reviewed for sound reasoning and accuracy

Accountabilities in this Role

• Quality Assurance responsibilities include but are not limited to 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

Qualifications and Experience

• 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

Physical Requirements

• Lifting: Frequent lifting between 50-75 lbs
• Ability to manage several tasks at the same time; Ability to focus on tasks ; Ability to evaluate operating conditions ; Ability to exercise sound judgment

Personal Protective Equipment

Must be able to work night shift. roughly 9pm – 9am (give or take a few hours – 8 hour shift) Sunday - Friday

Work Environment

The primary work environment consists of a pharmacy which must be kept clean, orderly, properly lighted and maintained in optimum operating condition. Employees handle radioactive materials and are exposed to very low amounts of radiation that are deemed safe by current standards. The facility is operated under well-controlled and closely monitored conditions that are regulated by both State and Federal agencies, and that are enforced by the corporate internal quality and regulatory group. Each staff member will receive specific training in keeping radiation exposures within regulatory guidelines and he/she will be routinely monitored for their exposure to radiation. Noise levels are considered low to moderate.

Compensation and Benefits

• Anticipated salary range: $76,700.00-$98,550.00 Bonus eligible: No
• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlexPay
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs

Application Window

Anticipated to close: 12/24/2026

Equal Opportunity and Diversity

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 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.

Company Overview

Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for healthcare facilities. We are a crucial link between the clinical and operational sides of healthcare, delivering end‑to‑end solutions and data‑driving insights that advance healthcare and improve lives every day. With deep partnerships, diverse perspectives and innovative digital solutions, we build connections across the continuum of care. With more than 50 years of experience, we seize the opportunity to address healthcare's most complicated challenges — now, and in the future.