Senior Specialist - Quality Assurance - Nights

225 Cardinal Health 414, LLC; United States; On-site; USD 77,000 - 99,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

401k savings plan

Paid time off

Health savings account (HSA)

FSAs

Short- and long-term disability

Work-Life resources

Paid parental leave

Job summary

Cardinal Health PET Manufacturing Services is seeking a Quality Assurance professional to help ensure CGMP-compliant product release and robust quality systems. The role supports cross-functional teams, reviews CGMP documentation, and helps drive improvements across facilities and processes.

The position emphasizes night shifts and involves lifting duties, with a Bachelor’s degree preferred in Chemistry or Biology and 1–2 years of QA/regulatory experience.

Qualifications

• 1-2 years experience in QA and/or regulated environment preferred
• Effective written and verbal English communication skills required
• Must be able to work NIGHTS, with start times around midnight or 1am

Responsibilities

• Applies working knowledge to perform varied tasks within CGMP context
• Works on projects of moderate scope and complexity
• Identifies possible solutions to technical problems and takes action to resolve
• Applies judgment within defined parameters and follows general guidance
• Supports CGMP documentation review related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production & process controls
• Engage with operations to drive quality system and CGMP requirements

Skills

QA experience

English communication

Night shift

Lifting 50-75 lbs

Education

B.S. in Chemistry or Biology

Job description

Cardinal Health PET Manufacturing Services

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.

Responsibilities

• 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

• 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

• 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

Anticipated salary range: $76,700.00-$98,550.00 Bonus eligible: No

Benefits

• 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

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.

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.