Senior Quality Assurance Specialist
4 days ago
The Senior Specialist, Quality Assurance plays a critical role in ensuring the quality of products and services at Cardinal Health. This position is responsible for executing quality programs, policies, and procedures in a particular area of specialty, such as recalls and customer complaints, to minimize risks and drive supply chain integrity.
Key Responsibilities- Ensures fulfillment of external reporting requirements related to area of specialty, such as submitting necessary materials for product recalls.
- Executes internal programs to define Quality guidelines and track adherence to these guidelines.
- Provides guidance to internal stakeholders regarding adherence to internal Quality Assurance policies and procedures as well as external requirements.
- Responds to significant quality issues and conducts root cause analyses, reports on relevant quality metrics and trends, and develops insights for internal stakeholders.
- Collaborates with Quality Assurance Specialists in other specialty areas as necessary to develop recommendations.
- Supports the Change Control Program by assessing Quality Assurance implications and impacts of operational and product changes.
- Updates standard operating procedures in response to product changes and regulatory developments.
- Prepares responses to regulatory queries, regulatory audits, and corporate audits and gathers necessary information from products and operations stakeholders.
- Supports the Manager, Quality Assurance in quality audits and inspections of distribution centers within the region.
- 2-4 years of experience in quality assurance or a related field.
- Bachelor's degree in a related field or equivalent work experience.
- cGMP experience highly preferred.
- Analytical equipment knowledge such as GC and HPLC.
Cardinal Health offers a wide variety of benefits and programs to support health and well-being, including medical, dental, and vision coverage, paid time off, health savings account, 401k savings plan, and more.
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