Principal Specialist, Quality Assurance
About The Position
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. This role applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects. May contribute to the development of policies and procedures. May act as a mentor to less experienced colleagues. Works on complex projects, technology transfer, sponsor drug products, training and review of Cardinal Health’s drug product portfolio. Develops quality solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives. Completes work independently; receives general guidance on new or existing projects. Work reviewed for purpose of meeting objectives. Interacts with customers where appropriate including drug product sponsors and suppliers. May assist in internal and/or external audits. Lead Quality investigations relating to material/vendor investigations.
Requirements
- PET Quality Experience, required
- Bachelors in related field, or equivalent work experience, preferred
- 4+ years’ experience in related field, preferred
- ASQ or equivalent certification, preferred
- Up to 50% travel required (flexible with travel, may include short notice)
Responsibilities
- 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 can perform gap assessments.
- 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 can interpret the requirements as well as educate others on those requirements.
- Lead Quality investigations relating to material/vendor investigations.
Benefits
- Medical, dental and vision coverage
- Paid time off (Untracked)
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Principal
