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 is responsible for providing regulatory submissions in electronic format – drug establishment and drug listing requirements for Structured Product Labeling (SPL) format for repackaging and private label Rx and OTC. This individual will contribute to the oversight of Cardinal Health Pharmaceutical Private Label and of approved suppliers, manufacturers and repackagers.
Responsibilities
- Contribute to designing effective procedures, work instructions and/or processes to ensure compliance as well as efficiency.
- Processing Electronic Registrations and Drug Listings for repackaging.
- Clear understanding of guidelines for Structured Product Labeling (SPL) for both Rx and OTC.
- Data development and maintenance for repackage items in portfolio.
- SOP development and maintenance.
- Determine compliance of processes and regulations.
- Identify potential gaps to mitigate risk
- Implement improvements to internal processes.
- Works on complex projects.
- Acts as a mentor to those with less experience.
- Other activities as requested.
Qualifications
- BA, BS or equivalent experience in related field preferred
- 3-5 years of experience preferred.
- Comprehensive experience with Structured Product Labeling (SPL) preferred.
- Knowledge of cGMPs, 21 CFR 11, 210, 211, 820 and Structured Product Labeling (SPL) requirements preferred.
- Comprehensive knowledge of repacking operations preferred.
- Demonstrate critical thinking skills.
- Proficient with Microsoft Excel.
- Comprehensive knowledge and familiarity with products, processes, equipment, and facilities of pharmaceutical manufacturing and packaging.
- Comprehensive experience with drug/cosmetic listings preferred.
- Ability to work independently.
- Able to multitask and to reprioritize as required.
- Excellent interpersonal and critical thinking skills.
- Ability to travel 5% for in person meetings and/or regulatory inspections.
Location
- Fully remote
- Ability to travel up to 5% required for in person meetings and/or regulatory inspections.
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: $66,500-$95,000
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: 03/29/2024 *if interested in opportunity, please submit application as soon as possible.
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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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