Chemical/Pharmaceutical, Quality Assurance (NIGHTS)

Cardinal Health

Posted 11 days ago

Full Time

Denver, Colorado

In Person

Smart Summary

Responsibilities

The Quality Assurance professional will ensure compliance with CGMP regulations by reviewing documentation, managing material and laboratory controls, and overseeing product release activities. They will also collaborate with the operations department to drive quality system improvements and report discrepancies to the regional management.

Qualifications

You have a Bachelor's of Science degree and 0-2 years of experience in a regulated environment, preferably in pharmaceuticals or medical devices. You possess strong written and verbal English communication skills and the ability to work night shifts, demonstrating knowledge of quality systems and regulatory requirements.

Must Have Skills for ATS

CGMP

21 CFR 212

Quality Assurance

Quality Systems

CAPA

Validation

Root Cause Analysis

Pharmaceutical

Medical Device

ISO

Job Description

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


What Quality Assurance contributes to Cardinal Health:

Quality Assurance is responsible for 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:

  • 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
  • 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

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.


Anticipated salary range: $76,700.00-$98,550.00

Bonus eligible: No

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

  • 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 *if interested in opportunity, please submit application as soon as possible.


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.

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.


To read and review this privacy notice click here

Cardinal Health

Cardinal Health is a distributor of pharmaceuticals and specialty products; a supplier of home-health and direct-to-patient products and services; an operator of nuclear pharmacies and manufacturing facilities; a provider of performance and data solutions; and a global manufacturer and distributor of medical and laboratory products. Our company’s customer-centric focus drives continuous improvement and leads to innovative solutions that improve people’s lives every day. Disclaimer: LinkedIn is a third-party site unaffiliated with Cardinal Health. Cardinal Health is not responsible for the privacy or security policies or practices on LinkedIn or on any of the third-party websites that we may link to through LinkedIn. You should carefully review the privacy and security practices of LinkedIn and linked third-party websites. We do not necessarily endorse any information found here nor are we responsible for the accuracy of any information, opinions, claims, or advice found here or shared here by our followers. By posting content, ideas, or pictures, you grant Cardinal Health a non-exclusive, royalty-free, perpetual, and worldwide license to use your content and any images posted by you, including the rights to copy, distribute, transmit, display, reproduce, edit, translate, and reformat, and incorporate into a collective work. Cardinal Health reserves all rights relating to the company's LinkedIn account, including removing postings and prohibiting individuals from participating on the page.
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