New · posted Nov 5
Cardinal Health · Pharmaceuticals
Senior Specialist - Quality Assurance - Nights
- Colton, CA
- On-site
- Full-time
- Senior & Principal
The role
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 you need
Accountabilities
- 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.
- Must be able to work NIGHTS
- Hours can start at midnight or 1am M-F located in Denver, CO
- Bachelor's of Science in Chemistry or Biology degree preferred
- Effective written and verbal English communication skills required
- 1-2 years experience in QA and/or regulated environment highly preferred - cGMP
- 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
Skills named in this posting
What you'll do
- 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
Pay and benefits
$76,700 – $98,550 a year
Employer providedAnticipated salary range: $76,700.00-$98,550.00
Medical, dental and vision coverage
Paid time off plan
Health savings account (HSA)
401k savings plan
Short- and long-term disability coverage
Paid parental leave
Where you'll work
Colton, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in Colton, CAWorking conditions
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.
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: 1/14/2027 *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.
Equal opportunity, accessibility and legal noticesCardinal Health's statements, word for word
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
Job intelligence
The context around this role
Live data · November 5, 2026
Salary intelligence
How the pay compares
This role's midpoint is 8% below the US median for Quality Operations & Batch Release roles at this level.
This roleEmployer provided
Senior & Principal roles in the US13 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $76,700 | — | $98,550 |
| All US (middle half) | $93,000 | $95,500 | $104,000 |
This role: Cardinal Health's own published range. Comparisons: the base pay employers published on open Quality Operations & Batch Release roles at the same level on Regulatory Jobs, November 5, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Operations & Batch Release
The general path across 87 open Quality Operations & Batch Release roles on Regulatory Jobs, with the titles they carry most. Not Cardinal Health's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 31 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance7
- Documentation and SOPs4
- Quality systems and risk4
- Collaboration and leadership3
- Lab testing and methods2
- Investigations and CAPA2
- Validation and qualification1
- Regulatory submissions1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Operations & Batch Release work in pharmaceuticals, led by the one this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- ICHICH Q10(official source, opens in a new tab)The pharmaceutical quality system across the product lifecycle
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDAFDA aseptic processing guidance(official source, opens in a new tab)Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice
- ICHICH Q7(official source, opens in a new tab)Good manufacturing practice for active pharmaceutical ingredients
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk management
- FDAFDA quality agreements guidance(official source, opens in a new tab)Contract Manufacturing Arrangements for Drugs: Quality Agreements
- FDADrug Supply Chain Security Act(official source, opens in a new tab)Product tracing, verification and serialization across the US drug supply chain
- EUEU Good Distribution Practice(official source, opens in a new tab)Guidelines on good distribution practice of medicinal products for human use
- FDA21 CFR Part 7(official source, opens in a new tab)FDA enforcement policy, including product recalls
- USPUSP–NF(official source, opens in a new tab)US Pharmacopeia general chapters and monographs, such as <61> bioburden, <85> endotoxin, <1225> validation
- PIC/SPIC/S(official source, opens in a new tab)The Pharmaceutical Inspection Co-operation Scheme and its GMP guide
- ISOISO 14644-1(official source, opens in a new tab)Cleanroom air cleanliness classification by particle concentration
Company hiring pulse
Cardinal Health on Regulatory Jobs
- 38
- Open roles
- 32
- Distinct roles
- 23
- Locations
By discipline
- Quality33 87%
- Regulatory4 11%
- Clinical1 3%
By level
- Senior & Principal23 61%
- Associate & Specialist8 21%
- Manager5 13%
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Senior Specialist - Quality Assurance - Nights at Cardinal Health
Open until filled. $77K–$99K a year, employer provided.