Senior Specialist, Quality Assurance

Senior Specialist, Quality Assurance - Pharmaceutical Private Label (Labeling Team)

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.

Job Summary

The Senior Specialist, Quality Assurance - Labeling Team is responsible for ensuring the accuracy, compliance, and quality of labeling components for pharmaceutical private label products. This role supports the Pharmaceutical Private Label operations by reviewing and approving labeling and maintaining documentation in accordance with current Good Manufacturing Practices (cGMP), FDA regulations, and internal procedures.

Responsibilities

Labeling Review & Approval :

Review and approve labeling components for all Pharmaceutical Private Label Cardinal Health owned brands.

Review and approve Master Batch Records from repackagers to ensure appropriate labeling utilized by repackagesr.

Determine criticality of label discrepancies using comparison software.

Review incoming source product labeling for accuracy and compliance.

Documentation & Compliance / Process Improvement & Collaboration :

Conduct gap assessments and proactively identify quality issues.

Develop, review, and implement QA procedures.

Collaborate across departments to ensure regulatory compliance and timely resolution of quality concerns.

Qualifications

2-4 years of experience, preferred

Bachelor's degree in related field, or equivalent work experience, preferred

Working knowledge of cGMP and FDA regulations.

Experience with quality management systems and labeling platforms (e.g., Veeva, Kallik, Global Vision).

Strong attention to detail and decision-making skills.

Ability to work independently and manage moderately complex projects.

Effective communication and collaboration skills across cross-functional teams.

Ability to make decisions that prioritize quality of product and labeling that may conflict with production priorities and ability to communicate those decisions in a diplomatic, productive manner.

Knowledge of FDA drug and device listing requirements.

Knowledge of drug listing submission processes via the Electronic Submissions Gateway (ESG) preferred.

Familiarity with regulatory documentation and compliance standards for pharmaceutical and medical device labeling.

Ability to interpret and apply regulatory guidance to ensure labeling accuracy and compliance.

Experience in maintaining and updating labeling records and revision logs for RX and OTC products.

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

Work reviewed for sound reasoning and accuracy

Anticipated salary range : $68,500 - $87,400

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 : 11 / 20 / 2025

• 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

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.

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