Senior Specialist, Quality Assurance

225 Cardinal Health 414, LLC; Fort Lauderdale (FL); On-site; USD 69,000 - 88,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off

Health savings account (HSA)

401k savings plan

Wages advance with myFlexPay

Flexible spending accounts (FSAs)

Disability coverage (short/long term)

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Job summary

Cardinal Health is seeking a Senior Specialist, Quality Assurance to support Nuclear Manufacturing tech transfer within the Technical Operations group. You will review protocols, validation and other docs, ensuring cGMP compliance and timely product release across the PET network.

Travel 50-75% to various PET sites; collaborate with Operations and quality leadership to drive CAPA, documentation control, and quality improvement initiatives.

Qualifications

• Bachelor’s degree in a related field or equivalent experience.
• 2+ years in a related science field preferred.
• 1-2 years in Quality Assurance and/or regulated environment preferred.
• cGMP experience preferred.
• Pharmaceutical or medical device experience a plus.
• ISO experience a plus.
• Effective written and verbal English communication skills.
• Ability to travel 50-75%.
• Proficiency with SAP and Microsoft Office tools.
• Understanding of quality systems and CAPA.

Responsibilities

• Deliver QA support for the review and approval on operational documentation for tech transfer.
• Travel to PET sites network-wide to review tech transfer projects.
• Review cGMP documentation related to product release, facilities and controls.
• Ensure site meets 21 CFR 212 (cGMP) requirements and manage documentation.
• Perform product release activities per cGMP requirements.
• Monitor CAPA investigations and closure.
• Perform aseptic review and report quality system issues.
• Review and disposition manufacturing docs (BMR/EM/validation/changes).
• Collaborate with Operations to drive quality systems and cGMP.
• Educate and influence others on quality requirements.

Skills

Quality concepts

Written and verbal English

Cross-functional collaboration

Problem solving

Education in related field

Education

Bachelor's degree in related field

Tools

SAP

Microsoft Excel

Microsoft Word

Microsoft Outlook

Microsoft PowerPoint

Job description

What Quality Assurance contributes to Cardinal Health Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Assurance develops and implements a compliant and cost-effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented. Cardinal Health PET Manufacturing Services is responsible for manufacturing PET radiopharmaceuticals to enhance patient treatment through improved disease diagnosis, staging, and monitoring.

Job Summary The Senior Specialist, Quality Assurance role will support, Nuclear Manufacturing. This is part of a growing Technical Operations team within Cardinal Health’s Nuclear and Precision Health Solutions organization tasked with the development and technology transfer of radiopharmaceutical products into and among our network of qualified manufacturing facilities. Tech Transfer projects are the leading priority for this Quality Assurance position.

Responsibilities

• Deliver QA support for the review and approval on all operational documentation as it relates to the technical transfer project such as protocols, validation documents, etc. This role will be accountable to the technical transfer leadership team while executing tech transfer projects.
• Travel to other PET manufacturing sites network-wide to provide quality review of technical transfer projects when required.
• Handle cGMP documentation review related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production & process controls. Establish metrics and report as required by the Regional Quality Manager.
• Ensure the site manufactures products to meet the requirements of 21 CFR 212 (cGMP). Handle and ensure quality of documentation (control, retention, and archival) to support cGMP activities. Engage and collaborate with Operations department to drive quality system and cGMP requirements.
• Perform product release activities per cGMP requirements. Monitor CAPA in investigations and close when completed or escalates if necessary.
• Perform aseptic review of the site with Operations and document results. Report quality system issues to the Regional Quality Manager and others as necessary.
• Review and disposition documentation in a timely manner, such as manufacturing batch records, EM records, validation documentation, change controls, process qualifications, on-site material preparations, equipment qualifications and/or planned maintenance, material acceptance, cleaning documents, etc.
• Work cross-functionally and interpret requirements, educate and influence others on those requirements.

Qualifications

• Bachelor's degree in related field, or equivalent work experience.
• 2+ years of experience in related science field (preferred).
• 1-2 years of experience in Quality Assurance and/or regulated environment (preferred).
• cGMP experience, highly preferred.
• Pharmaceutical or medical device experience, a plus.
• ISO experience, a plus.
• Effective written and verbal English communication skills.
• Ability to manage several tasks at the same time; focus on tasks; evaluate operating conditions; exercise sound judgment.
• Personal Protective Equipment experience.
• Knowledge of quality systems and approaches.
• Proficiency with SAP, Microsoft Excel, Microsoft Word, Microsoft Outlook, and Microsoft Power Point.
• Understanding of requirements and gap assessments.
• Ability to analyze and interpret results from chromatograms by HPLC, Gas Chromatography, and E-Z Scan radiometric TLC scanner, a plus.
• Understanding of quality concepts such as cost of quality, analytical metrics and/or statistics, trending, quality planning, validation, CAPA and problem solving, a plus.
• Ability to travel 50%-75%.

Work Environment

The primary work environment consists of a manufacturing 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 will be routinely monitored for their exposure to radiation. Noise levels are considered low to moderate.

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 action to resolve; applies judgment within defined parameters; receives general guidance and may receive more detailed instruction on new projects; works reviewed for sound reasoning and accuracy.

Salary and Benefits

Anticipated salary range: $68,500.00-$88,020.00. 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: 11/8/2026. 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. Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply. 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/Affirmative Action 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.

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